Application of PPE in Response to COVID-19 Pandemic
PERSONAL PROTECTIVE EQUIPMENT (PPE)
The need for PPE should be based on the anticipated exposure to the blood and body substance and precautions should be based on the mode of transmission of the infectious agents.
The COVID-19 virus is spread mainly from person-to-person in close contact with one another, through respiratory droplets produced when an infected person coughs or sneezes and by the host touching a surface or object that has the virus on it and then touching mucus membrane.
The precautions applied for COVID-19 includes contact and droplet precautions with the addition of airborne for aerosol generating procedures (AGPs), hand hygiene and environmental cleaning (including shared equipment).
The PPE should be elected according to the manufacturer’s product label that describes an intended use with the desired level of protection, based on the risk levels of care provided.
Considerations when using a gown for suspected or confirmed cases
When minimal liquid penetration is expected a :
- Level 1 barrier gown is sufficient for personal protection;
- Level 2 barrier protection is required when having close contact with symptomatic COVID-19 patients. For AGPs with COVID-19 patients,
- Level 3-4 barrier protection is recommended. Refer to Appendix 1 for more information.
Considerations when using a surgical mask for suspected or confirmed cases
In the majority of situations where standard respiratory protection is needed, a single use surgical mask is appropriate (minimum Level 1 barrier). Refer to Appendix 2 for AS 4381: 2015 Single use surgical face mask standard.
- Masks should be changed between patients and when they become soiled or wet
- Masks should never be reapplied after they have been removed
- Masks should not be left dangling around the neck
- Touching the front of the mask while wearing it should be avoided
- Hand hygiene should be performed upon touching or discarding a used mask.
HIGH PARTICULATE RESPIRATORS (P2/N95) MASKS
P2 respirators are designed to help reduce the wearer’s respiratory exposure to airborne contaminants such as particles, gases or vapours.
For COVID-19 the use of P2/N95 masks should be reserved for AGPs or where the risk assessment places the patient in airborne precautions.
When there is a high probability of aerosol transmission due to the infectious agent or procedure
e.g. bronchoscopy, sound scientific principles support the use of a P2 mask to prevent transmission.
While the terms ‘P2 mask and ‘N95 mask are often used interchangeably in the healthcare setting, they are required to meet different standards.
In Australia, the requirements for P2 masks are stated in Standard AS/NZS 1716: 2012.
The United States (US) National Institute of Occupational Safety and Health (NIOSH) specifies N95 mask requirements.
The N95 versus P2 is associated with the testing requirements for compliance as respiratory protection.
See Table 1 for properties of the two masks.
Table 1: Properties of P2 and N95 masks
| PROPERTIES | P2 MASKS | N95 MASKS |
| Other names | N95 masks, respiratory protection device, particulate respirator | P2 respirator, respiratory protection device, particulate respirator |
| Characteristics | Raised dome or duckbill4–5 layers (outer polypropylene, central layers electret [charged polypropylene])Filtration through mechanical impaction and electrostatic captureDesigned to provide a good facial fit to minimise aerosol contamination of the mucous membranes of the nose and mouth P2 particulate filtering respirators/ masks must have a filter efficiency of at least 94% when tested with sodium chloride aerosol at a flow rate of 95 litres/minute. Under the EN system, aerosol testing is similar to Standard AS/ NZS 1716: 2012, but have additional filter efficiency testing with paraffin oil aerosol that must also meet the minimum 94% filter efficiency to be classified as P2. The particle size of this aerosol has a mass median diameter of 0.3 to 0.6 microns with a range of particles in the 0.02 to 2 micron size range. | Raised dome or duckbill4–5 layers (outer polypropylene, central layers electret [charged polypropylene])Filtration through mechanical impaction and electrostatic captureDesigned to provide a good facial fit to minimise aerosol contamination of the mucous membranes of the nose and mouth NIOSH classified N95 particulate filtering respirators/masks must have a filter efficiency of at least 95% when tested with sodium chloride aerosol at a flow rate of 85 litres/minute. N95 respirator masks can only be used for oil free aerosols. The particle size of this aerosol ~0.3 micron. |
| Sealing | Ties at crown and bottom of head, pliable metal nose bridgeFit testing and fit checking recommended | Ties at crown and bottom of head, pliable metal nose bridgeFit testing and fit checking recommended |
| Australian Standards | Standard AS/NZS 1715: 2009 Standard AS/NZS 1716: 2012 | Set by the US NIOSH classification (NIOSH Guidelines – Procedure No. TEB-APR-STP-0059) |
| Intended use | Routine care of patients on airborne precautionsHigh-risk procedures such as bronchoscopy when the patient’s infectious status is unknownProcedures that involve aerosolisation of particles that may contain specific known pathogens (AGPs) | Routine care of patients on airborne precautionsHigh-risk procedures such as bronchoscopy when the patient’s infectious status is unknownProcedures that involve aerosolisation of particles that may contain specific known pathogens (AGPs) |
| Notes | Care must be taken if placing respirators on patients and must suit clinical need i.e. if the patient has chronic obstructive airways disease (COAD) or is in respiratory distress, the respirator will exacerbate symptoms. | Care must be taken if placing respirators on patients and must suit clinical need i.e. if the patient has chronic obstructive airways disease (COAD) or is in respiratory distress, the respirator will exacerbate symptoms. |
IS A SURGICAL MASK A N95 RESPIRATOR ?
No. Surgical masks are not designed for use as particulate respirators and do not provide as much respiratory protection as an N95 respirator.
Surgical masks provide barrier protection against droplets including large respiratory particles.
Most surgical masks do not effectively filter small particles from the air and do not prevent leakage around the edge of the mask when the user inhales.[Reference: Rengasamy,S., B.C.Eimer, and R.E.Shaffer. (2009) Filtration performance of FDA-Cleared surgical masks. Journal International Society Respiratory Protection 26; 54-70.]
OSHA Video: The Difference Between Respirators and Surgical Masks
Do surgical masks provide protection against SARS – COVID-19?
Surgical masks are not designed for use as particulate respirators and do not provide as much protection as an N-95 respirator. Most surgical masks do not effectively filter small particles from air and do not prevent leakage around the edge of the mask when the user inhales.
If surgical masks do not protect against airborne diseases, why are surgical masks suggested for use against SARS/COVID-19 when no N-95 respirators are available?
Surgical masks are recommended only as a last resort for health care and medical transport workers exposed to SARS/COVID-19 patients when no NIOSH-approved respirator equivalent to or greater than the N-95 is available.
SARS/COVID-19appears to be transmitted mainly through direct contact with infectious materials (including large respiratory particles), and surgical masks will provide barrier protection against droplets that are considered to be the primary route of SARS/COVID-19 transmission.
However, surgical masks may not adequately protect against aerosol or airborne particles, primarily because they do not effectively filter small particles from the air, they allow leakage around the mask, and they cannot be fit tested.
Because scientists cannot currently rule out the spread of SARS/COVID-19 through the air, CDC recommends a NIOSH-approved respirator equivalent to or greater than the N-95.
Surgical masks may also be placed on patients with communicable conditions like SARS/COVID-19 to contain respiratory droplets and prevent spread of infectious particles.
FIT CHECKING AND FIT TESTING
Fit Checking
Fit checking at time of use is the most reliable method of ensuring the healthcare worker has achieved the required seal in real time.
Fit checking (user-seal check) describes the process that health workers perform each time a respirator is donned to check that a good facial seal is achieved i.e. the respirator is sealed over the bridge of the nose and mouth and there are no gaps between the respirator and the face.
Fit checking is a process used for all P2/N95 masks regardless of whether or not fit tested.
In NSW Health much of the testing and education for fit checking is with duckbill type masks but it should be highlighted there are differences depending on which mask is in use, and manufacturer’s instructions for specific mask fit check should always be followed.
Refer to Principles of Fit Checking for the procedure for performing a fit check.
In normal circumstances a service should have access to various masks to suit the range of staff. Refer to Appendix 3 for available P2/N95 Mask Range within NSW Health.
Fit Testing
Fit testing is performed to determine whether a specific type, model and size of respirator is a suitable fit for an individual and that it is worn correctly to achieve a facial seal.
Fit testing may use quantitative or qualitative methods:
- quantitative methods use electronic equipment that measures air leakage into the respirator
- qualitative methods use a hood and an odour or taste solution to determine the ability of the respirator wearer to smell or taste the test agent.
Application and barrier level of different types of PPE
P2/N95 masks must be prioritised for health workers performing AGPs, including tracheal intubation, bronchial suctioning, bronchoscopy, and induced sputum.
P2/N95 masks can be used for up to 4 hours for multiple patients without removing them unless the mask is damaged, soiled or contaminated, for example a symptomatic suspected case coughing on them.
Surgical mask Level 2-3 must be prioritised for symptomatic confirmed cases of COVID-19, followed by suspected cases. See Table 2 explaining the indications and required level of protection for different types of PPE.
Table 2: Application and barrier level of different types of PPE
| GOWN | SURGICAL MASK | P2/N95 MASK |
| Level 1 barrier performance | Level 1 barrier performance | P2/N95 mask with fluid resistance property |
| o Minimal contact with COVID-19 suspected or confirmed cases with acute respiratory illness e.g. fever clinic assessments Respiratory specimen collection in fever clinics with minimal physical contactAssessment of patients in GP practice or outpatient clinics | Health workers Procedures where low amounts of fluid, spray and/or droplets are produced* e.g. collecting respiratory specimens in low symptomatic patients NB eye protection is also recommendedProcedure involving MRI or any procedure involving minimal risk of exposure to droplets or other body substancesProtect health workers and/or the patient from droplet exposure to microorganisms e.g. patient with upper respiratory tract infection Community People on home isolation (people with symptoms of acute respiratory illness while in close proximity with other people e.g. in the same roomPeople with acute respiratory illness if needing to leave home for any reason e.g. visiting a medical facilityPatients suspected or confirmed with COVID-19 during transit | P2/N95 respirators are only required for aerosol generating procedures (AGPs) or prolonged contact with critically ill patients – high volume/high frequency of care Examples of AGPs: tracheal intubationnon-invasive ventilation tracheotomycardiopulmonary resuscitationmanual ventilation before intubation and bronchoscopy or bronchoalveolar lavagedental and/or maxillary-facial procedures The use of nebulisers should be avoided and alternative medication administration devices used e.g. spacers or isolation tents NB: If a health worker remains in a patient room for a long period because of the need to perform multiple procedures, the use of a powered air purifying respirator (PAPR) may be considered for additional comfort and visibility Use of PAPR requires training, education and competency assessment of staff prior to implementation |
| GOWN | SURGICAL MASK | |
| Level 2 barrier performance | Level 2 barrier performance | |
| o Close contact with symptomatic COVID-19 suspected or confirmed patients | Procedures where moderate to low amounts of fluid, spray and/or droplets are produced (including surgery) When providing care for symptomatic suspected/confirmed COVID- 19 cases within <1.5 metres Use with eye protection | |
| Level 3 and 4 barrier performance | Level 3 barrier performance | |
| o Aerosol generating procedures (AGPs) with COVID-19 patients e.g. intubation, bronchoscopy, prolonged contact with critically ill patients, dental and/or maxillary-facial procedures | Procedures where moderate to low amounts of fluid, spray and/or droplets are produced (including surgery) When providing care for symptomatic suspected/confirmed COVID- 19 cases within <1.5 metres Use with eye protection |
Table 3: PPE guidance for care of patients with suspected/confirmed COVID-19
| PPE | Outpatient settings contact <1.5 Meter of Symptomatic Cases | Patient Contact >1.5 Meter | Patient Contact <1.5 Meter Of Symptomatic Case | High Risk Patient Environment# Contact <1.5 Meter | AGP |
| Disposable Gloves | YES | NO | YES | YES | YES |
| Disposable Plastic / impervious Apron | YES | NO | YES | YES | NO |
| Disposable Plastic / impervious Gown | RISK ASSESS** | NO | RISK ASSESS | RISK ASSESS | YES |
| Fluid Resistant Surgical Mask Level 2 -3 | YES | NO | YES | YES | NO |
| P2/N95 Mask | NO | NO | NO | RISK ASSESS | YES |
| Eye Protection | YES | NO | YES | YES | YES |
** Risk assessment is the individual assessment of the anticipated likelihood and amount of exposure to blood and or body substances through spray/splash resulting in the need for a barrier protection.
# High risk patient environment is considered to be those inpatient environments where multiple COVID-19 cases are isolated/managed in one place e.g. COVID-19 management units
Appendix 1: AAMI Level Standards for Gowns
| Barrier Performance | Barrier Protection | Resistance Measure | Description |
| Level 1 | Minimal | Liquid penetration | Used for MINIMAL risk situations Provides a slight barrier to small amounts of fluid penetration Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance. |
| Level 2 | Low | Liquid penetration | Used in LOW risk situations Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking Two tests are conducted to assess barrier protection performance: Water impacting the surface of the gown materialPressurizing the material |
| Level 3 | Moderate | Liquid penetration | Used in MODERATE risk situations Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2 Two tests are conducted to test barrier protection performance: Water impacting the surface of the gown materialPressurizing the material |
| Level 4 | High | Liquid and viral penetration | Used in HIGH risk situations Prevents all fluid penetration for up to 1 hour May prevent VIRUS penetration for up to 1 hour In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus – if no virus is found at the end of the test, the gown passes |
NB: the above does not include classification for chemotherapy gowns Plastic (or polyethylene gowns/aprons are fluid impervious.
Appendix 2: AS 4381:2015 Single use surgical face mask standard
| AS 4381:2015 SINGLE USE FACE MASK | ||||
| Characteristics | Level 1 Barrier | Level 2 Barrier | Level 3 Barrier | Test method |
| For procedures, | For procedures | For procedures such | ||
| where the wearer is | where the wearer is | as major trauma first | ||
| not at risk of blood or | at risk of moderate | aid or in any area | ||
| bodily substance | exposure to blood | where the health | ||
| Application | splash or to protect staff and/or the patient from droplet | and body substances e.g. surgery, dentistry, | worker is at risk of substantial exposure to blood or bodily | N/A |
| exposure to | general patient care | substance splash | ||
| microorganisms e.g. | areas; to protect | e.g. orthopaedic, | ||
| patient with upper | staff and/or the | cardiovascular | ||
| respiratory tract | patient from droplet | procedures | ||
| infection | exposure | |||
| Bacterial Filtration | ASTM | |||
| Efficiency (BFE) % | ≥ 95% | ≥ 98% | ≥ 98% | F2101-14 or EN |
| 14683:2014 | ||||
| Particulate | ||||
| Filtration Efficiency (PFE) % (0.1 μm) | < 4.0 | < 5.0 | < 5.0 | EN 14683:2014 |
| Resistance to penetration by synthetic blood (fluid | 80mm Hg | 120mm Hg | 160mm Hg | ASTM F1862 /F1862M-13 or ISO 22609 |
| resistance) min | ||||
| pressure in mm | ||||
| Hg for pass result |
Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators
Other countries approve respirators for occupational use and approve respirators to these standards.
These products are evaluated using some methods similar to those used by NIOSH, and some methods that are different, but are expected to protect HCPs.
These respirators are expected to provide protection to workers.
Those with equivalent or similar protection to NIOSH-approved respirators may be available to provide respiratory protection to workers exposed to harmful airborne particulate matter.
These devices are expected to be suitable alternatives to provide protection during the COVID-19 response when supplies are short.
The country, conformity assessment standards, acceptable product classifications, standards and guidance documents, and protection factor determination are provided in alphabetical order.
All of these respirators have protection factors of at least 10 in the countries listed below, as outlined in the standards and guidance documents specified.
Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators
| Country | Performance Standard | Acceptable product classifications | Standards/Guidance Documents | Protection Factor ≥ 10 |
| Australia | AS/NZS 1716:2012 | P3 P2 | AS/NZS 1715:2009 | YES |
| Brazil | ABNT/NBR 13698:2011 | PFF3 PFF2 | Fundacentro CDU 614.894 | YES |
| China | GB 2626-2006 | KN 100 KP100 KN95 KP95 | GB/T 18664—2002 | YES |
| Europe | EN 149-2001 | FFP3 FFP2 | EN 529:2005 | YES |
| Japan | JMHLW-2000 | DS/DL3 DS/DL2 | JIS T8150: 2006 | YES |
| Korea | KMOEL-2017-64 | Special 1st | KOSHA GUIDE H-82-2015 | YES |
| Mexico | NOM-116-2009 | N100, P100, R100 N99, P99, R99 N95, P95, R95 | NOM-116 | YES |
| US NIOSH Requirements | NIOSH approved 42 CFR 84 | N100, P100, R100 N99, P99, R99 N95, P95, R95 | OSHA 29CFR1910.134 | YES |
Before going into the analysis of production standards and the real characteristics of the masks produced around the world, I want to deepen the theme of the masks produced in China.
Please bear in mind:
Only those that meet the certain pharmaceutical industry standard ( in China the standard is YY0469-2011) can be called “medical surgical masks”.
Let’s dive into the types of medical masks first.
According to the literature of the Beijing Medical Device Inspection Institute’s materials, currently China’s medical masks are mainly divided into three types:
- Medical protective mask with the highest protection level;
- Medical surgical masks commonly used in invasive operating environments such as operating rooms;
- Ordinary grade disposable medical masks
Firstly, medical protective masks
What does a medical mask look like?
Equivalent to cup-shaped mask. Common arches and butterflies are shown in the figure below.
Compared with long medical surgical masks and ordinary medical masks, medical protective masks have a good fit with the wearer’s face, can filter particles in the air, and block pollutants such as droplets, blood, body fluids and secretions The filtration efficiency of non-oily particles can reach 95%.
Medical Surgical Masks
Medical surgical masks, which implement the standard YY0469-2011(China’s Standard of Medical Surgical Masks), are commonly used medical masks in operating rooms and other environments where there is a risk of bodily fluids and blood splashes.
They can block blood and bodily fluids from passing through the masks and contaminate the wearer.
At the same time, the filtration efficiency of bacteria is over 95%.
However, the filtration efficiency of particles is limited, and most of them have a rectangular design, and the adhesion to the face is not as tight as that of a medical protective mask.
Common medical surgical masks include strap type and ear hook type.
Third, ordinary medical masks
Ordinary medical masks have many names (medical care and disposable medical belong to this category). Medical masks without the words “protection” and “surgical” are ordinary medical masks.
It is not required to have a barrier effect on blood, and there is no requirement for tightness, so it is only used for wearing in a general medical environment.
The common ordinary medical masks are mostly ear-hung, and their appearance is similar to that of ear-hung surgical masks, as shown below.
What is N95 and what does it have to do with medical protective masks?
The N95 mask is one of nine anti-particulate masks certified by NIOSH (National Institute of Occupational Safety and Health).
Particulate matter protective masks, commonly known as dust masks, are a kind of special labor protection products.
Domestic production of particulate matter protective masks requires an industrial product production license, and the products should meet the mandatory national standard GB2626-2006.
“N” means oil-resistant particles (not resistant to oil, the oil fume produced by cooking is oily particles, and the droplets produced by people speaking or coughing are not oily); “95” refers to the NIOSH standard Under the detection conditions, the filtration efficiency reached 95%.
N95 is not a specific product name.
As long as the product meets the N95 standard and passes the NIOSH review, it can be called a “N95 mask”.
| Filter Materials Classification | Filtering Efficiency 95% | Filtering Efficiency 99% | Filtering Efficiency 99.97% |
| N | N95 | N99 | N100 |
| R | R95 | R99 | R100 |
| P | P95 | P99 | P100 |
Respirators are rated “N,” if they are Not resistant to oil, “R” if somewhat Resistant to oil, and “P” if strongly resistant (oil Proof)
Package Identification Requirements: In addition to the product model and trademark, the words “NIOSH”, the filtering efficiency level, and the NIOSH certification number of the product are also marked.
This number can be queried on the NIOSH official website for users to verify information, such as: NIOSH N95 TC-84A-0007.
Please be noted that those produced in China that meet the corresponding Chinese standard GB2626-2006 are called KN95.
| Filter Materials Classification | Filtering Efficiency 90% | Filtering Efficiency 95% | Filtering Efficiency 99.97% |
| KN | KN90 | KN95 | KN100 |
| KP | KP90 | KP95 | KP100 |
KN: Suitable for preventing non-oily particles, such as various types of dust, smoke, KP: Suitable for preventing non-oily particles and oily particles. Typical oily particles such as soot, oil mist, asphalt smoke, diesel particulates and coke oven smoke.
Package Identification Requirements: In addition to the product model and trademark, the filtering efficiency level, and the certification number of the product are also marked, such as: GB2626-2006 KN95
For masks that comply with the European standard EN149-2001, they are called FFP masks.
FFP masks are suitable for both non-oily and non-oily particles, but they are also classified into three different levels according to different filtering efficiency, as shown in the figure:
| Filter Materials Classification | FFP1* | FFP2* | FFP3* |
| Filtering Efficiency | 80% | 94% | 99% |
*Note: Suitable for both oil particles and non-oily particles
Package Identification Requirements: In addition to the product model and trademark, the filtering efficiency level, and the certification number of the product are also marked, such as: EN149-2001 FFP3 CE0121.
The N95 mask has a filtration efficiency of more than 95% for particles with an aerodynamic diameter ≥ 0.3µm.
The aerodynamic diameter of air bacteria and fungal spores mainly varies between 0.7-10µm, and it is also within the protective range of N95 masks.
Therefore, N95 masks can be used for respiratory protection of certain particulates, such as dust generated during grinding, cleaning and processing of minerals, flour and certain other materials.
It is also suitable for liquid or non-oily non-production caused by spraying.
Hazardous volatile gas particles. Can effectively filter and purify the inhaled abnormal odors (except toxic gases), help reduce the exposure level of certain inhalable microbial particulates (such as mold, anthrax, tuberculosis, etc.), but cannot eliminate contact infection, illness or death risks of.
The US Department of Labor has recommended that medical personnel use N95 masks to prevent microbial airborne diseases such as influenza and tuberculosis.
Take coronavirus as an example (2019-nCoV is a kind of coronavirus), with an average diameter of about 100nm, that is, 0.1.um, plus a propagation vector, such as droplets of about 1-5um in diameter, and N95 filters 0.3um non-oily particles With an effect of ≥95%, N95 can achieve effective filtration.
If it is a hospital-specific N95 mask, it is the aforementioned medical protective mask, that is, the material of the outer surface of the mask has the ability to block pressure body fluid from splashing and penetrating.
While meeting the NIOSH requirements, it must also meet GB19083-2010 Medical requirements.
What is GB19083-2010 for medical protective masks and YY0469-2011 for medical surgical masks?
A2: The picture below is the standard comparison of three masks.
| Medical Mask | YY/T 0969-2013 | YY 0469-2011 | GB 19083-2010 |
| Name | One-time-use medical face mask | Surgical Mask | Protective face mask for medical use |
| Application | Suitable for covering the mouth, nose and jaw of the user, and is a disposable mask for wearing in ordinary medical environment, and blocking the pollutants exhaled or sprayed out of the mouth and nose. | Disposable masks suitable for use by clinical medical personnel during invasive procedures. It is used to cover the user’s mouth, nose, and jaw, and provides a physical barrier to prevent direct penetration of pathogenic microorganisms, body fluids, particulate matter, etc. | Self-priming filtering medical protective mask suitable for filtering particulates in air, blocking droplets, blood, body fluids, secretions, etc. in medical working environments… |
| Subjects for testing the filtering efficiency | Bacterial aerosol MPS: 3um | Bacterial aerosol MPS: 3um | NaCl aerosol CMD: 0.075um MMAD: 0.24um |
| Bacterial filtering efficiency | ≥ 95% | ≥ 95% | Not available |
| Particles filtering efficiency | Not available | ≥ 30% (Non-oily particles) | Level 1: ≥ 30% Level 2: ≥ 99% Level 3: ≥ 99.97% (Non-oily particles) |
| Ventilation resistance | ≤ 49 Pa （Gas flow: 8L/min） | ≤ 49 Pa （Gas flow: 8L/min） | ≤ 343.2 Pa （Gas flow: 85L/min） |
| Synthetic blood penetration | Not available | 2ml of synthetic blood is sprayed on the outer side of the mask at a pressure of 16.0kpa (120 mmHg). The inner side of the mask should not penetrate. | 2ml of synthetic blood is sprayed on the outer side of the mask at a pressure of 10.07kpa (80 mmHg). The inner side of the mask should not penetrate. |
The outer packaging of the product is printed with YY0469-2011 standard, which can be confirmed as a medical surgical mask.
Someone said online that the spelling of the name of the mask’s outer packaging completely conforms to the six words “medical surgical masks” is also a way to determine whether it is a medical surgical mask. Is it true?
Not exactly! In fact, because of different manufacturers and different product batches, these six words may not all be there.
Limited re-use of N95 respirators for COVID-19 patients
Limited re-use of N95 respirators when caring for patients with COVID-19 might become necessary.
he recommendations are intended for use by professionals who manage respiratory protection programs in healthcare institutions to protect health care workers from job-related risks of exposure to infectious respiratory illnesses.
Supplies of N95 respirators can become depleted during an influenza pandemic (1-3) or wide-spreadoutbreaks of other infectious respiratory illnesses.(4) Existing CDC guidelines recommend a combination of approaches to conserve supplies while safeguarding health care workers in such circumstances. These existing guidelines recommend that health care institutions:
- Minimize the number of individuals who need to use respiratory protection through the preferential use of engineering and administrative controls;
- Use alternatives to N95 respirators (e.g., other classes of filtering facepiece respirators, elastomeric half-mask and full facepiece air purifying respirators, powered air purifying respirators) where feasible;
- Implement practices allowing extended use and/or limited reuse of N95 respirators, when acceptable; and
- Prioritize the use of N95 respirators for those personnel at the highest risk of contracting or experiencing complications of infection.
This document focuses on one of the above strategies, the extended use and limited reuse of N95 respirators only; please consult the CDC or NIOSH website for guidance related to implementing the other recommended approaches for conserving supplies of N95 respirators.
There are also non-emergency situations (e.g., close contact with patients with tuberculosis) where N95 respirator reuse has been recommended in healthcare settings and is commonly practiced.(5-9) This document serves to supplement previous guidance on this topic.
Definitions
Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several patients, without removing the respirator between patient encounters.
Extended use may be implemented when multiple patients are infected with the same respiratory pathogen and patients are placed together in dedicated waiting rooms or hospital wards.
Extended use has been recommended as an option for conserving respirators during previous respiratory pathogen outbreaks and pandemics.(10, 11)
Reuse1 refers to the practice of using the same N95 respirator for multiple encounters with patients but removing it (‘doffing’) after each encounter.
The respirator is stored in between encounters to be put on again (‘donned’) prior to the next encounter with a patient. For pathogens in which contact transmission (e.g., fomites) is not a concern, non-emergency reuse has been practiced for decades.(7)
For example, for tuberculosis prevention, CDC recommends that a respirator classified as disposable can be reused by the same worker as long as it remains functional2 and is used in accordance with local infection control procedures.(9)
Even when N95 respirator reuse is practiced or recommended, restrictions are in place which limit the number of times the same FFR is reused.
Thus, N95 respirator reuse is often referred to as “limited reuse”.
Limited reuse has been recommended and widely used as an option for conserving respirators during previous respiratory pathogen outbreaks and pandemics.(2, 3, 10-12)
Implementation
The decision to implement policies that permit extended use or limited reuse of N95 respirators should be made by the professionals who manage the institution’s respiratory protection program, in in consultation with their occupational health and infection control departments with input from the state/local public health departments.
The decision to implement these practices should be made on a case by case basis taking into account respiratory pathogen characteristics (e.g., routes of transmission, prevalence of disease in the region, infection attack rate, and severity of illness) and local conditions (e.g., number of disposable N95 respirators available, current respirator usage rate, success of other respirator conservation strategies, etc.).
Some healthcare facilities may wish to implement extended use and/or limited reuse before respirator shortages are observed, so that adequate supplies are available during times of peak demand.
For non-emergency (routine) situations, current CDC recommendations (6, 9) specific to that pathogen should also be consulted.
The following sections outline specific steps to guide implementation of these recommendations, minimize the challenges caused by extended use and reuse, and to limit risks that could result from these practices.
Respirator Extended Use Recommendations
Extended use is favored over reuse because it is expected to involve less touching of the respirator and therefore less risk of contact transmission.
Please see the section on Risks of Extended Use and Reuse of Respirators for more information about contact transmission and other risks involved in these practices.
A key consideration for safe extended use is that the respirator must maintain its fit and function. Workers in other industries routinely use N95 respirators for several hours uninterrupted.
Experience in these settings indicates that respirators can function within their design specifications for 8 hours of continuous or intermittent use.
Some research studies (14, 15) have recruited healthcare workers as test subjects and many of those subjects have successfully worn an N95 respirator at work for several hours before they needed to remove them.
Thus, the maximum length of continuous use in non-dusty healthcare workplaces is typically dictated by hygienic concerns (e.g., the respirator was discarded because it became contaminated) or practical considerations (e.g., need to use the restroom, meal breaks, etc.), rather than a pre-determined number of hours.
If extended use of N95 respirators is permitted, respiratory protection program administrators should ensure adherence to administrative and engineering controls to limit potential N95 respirator surface contamination (e.g., use of barriers to prevent droplet spray contamination) and consider additional training and reminders (e.g., posters) for staff to reinforce the need to minimize unnecessary contact with the respirator surface, strict adherence to hand hygiene practices, and proper Personal Protective Equipment (PPE) donning and doffing technique.(16) Healthcare facilities should develop clearly written procedures to advise staff to take the following steps to reduce contact transmission after donning:
- Discard N95 respirators following use during aerosol generating procedures.
- Discard N95 respirators contaminated with blood, respiratory or nasal secretions, or other bodily fluids from patients.
- Discard N95 respirators following close contact with, or exit from, the care area of any patient co-infected with an infectious disease requiring contact precautions.
- Consider use of a cleanable face shield (preferred3) over an N95 respirator and/or other steps (e.g., masking patients, use of engineering controls) to reduce surface contamination.
- Perform hand hygiene with soap and water or an alcohol-based hand sanitizer before and after touching or adjusting the respirator (if necessary for comfort or to maintain fit).
Extended use alone is unlikely to degrade respiratory protection. However, healthcare facilities should develop clearly written procedures to advise staff to:
- Discard any respirator that is obviously damaged or becomes hard to breathe through.
Respirator Reuse Recommendations
There is no way of determining the maximum possible number of safe reuses for an N95 respirator as a generic number to be applied in all cases.
Safe N95 reuse is affected by a number of variables that impact respirator function and contamination over time.(18, 19)
However, manufacturers of N95 respirators may have specific guidance regarding reuse of their product.
The recommendations below are designed to provide practical advice so that N95 respirators are discarded before they become a significant risk for contact transmission or their functionality is reduced.
If reuse of N95 respirators is permitted, respiratory protection program administrators should ensure adherence to administrative and engineering controls to limit potential N95 respirator surface contamination (e.g., use of barriers to prevent droplet spray contamination) and consider additional training and/or reminders (e.g., posters) for staff to reinforce the need to minimize unnecessary contact with the respirator surface, strict adherence to hand hygiene practices, and proper PPE donning and doffing technique, including physical inspection and performing a user seal check.(16) Healthcare facilities should develop clearly written procedures to advise staff to take the following steps to reduce contact transmission:
- Discard N95 respirators following use during aerosol generating procedures.
- Discard N95 respirators contaminated with blood, respiratory or nasal secretions, or other bodily fluids from patients.
- Discard N95 respirators following close contact with any patient co-infected with an infectious disease requiring contact precautions.
- Consider use of a cleanable face shield (preferred3) over an N95 respirator and/or other steps (e.g., masking patients, use of engineering controls), when feasible to reduce surface contamination of the respirator.
- Hang used respirators in a designated storage area or keep them in a clean, breathable container such as a paper bag between uses. To minimize potential cross-contamination, store respirators so that they do not touch each other and the person using the respirator is clearly identified. Storage containers should be disposed of or cleaned regularly.
- Clean hands with soap and water or an alcohol-based hand sanitizer before and after touching or adjusting the respirator (if necessary for comfort or to maintain fit).
- Avoid touching the inside of the respirator. If inadvertent contact is made with the inside of the respirator, discard the respirator and perform hand hygiene as described above.
- Use a pair of clean (non-sterile) gloves when donning a used N95 respirator and performing a user seal check. Discard gloves after the N95 respirator is donned and any adjustments are made to ensure the respirator is sitting comfortably on your face with a good seal.
To reduce the chances of decreased protection caused by a loss of respirator functionality, respiratory protection program managers should consult with the respirator manufacturer regarding the maximum number of donnings or uses they recommend for the N95 respirator model(s) used in that facility.
If no manufacturer guidance is available, preliminary data(19, 20) suggests limiting the number of reuses to no more than five uses per device to ensure an adequate safety margin.
Management should consider additional training and/or reminders for users to reinforce the need for proper respirator donning techniques including inspection of the device for physical damage (e.g., Are the straps stretched out so much that they no longer provide enough tension for the respirator to seal to the face?, Is the nosepiece or other fit enhancements broken?, etc.).
Healthcare facilities should provide staff clearly written procedures to:
- Follow the manufacturer’s user instructions, including conducting a user seal check.
- Follow the employer’s maximum number of donnings (or up to five if the manufacturer does not provide a recommendation) and recommended inspection procedures.
- Discard any respirator that is obviously damaged or becomes hard to breathe through.
- Pack or store respirators between uses so that they do not become damaged or deformed.
Secondary exposures can occur from respirator reuse if respirators are shared among users and at least one of the users is infectious (symptomatic or asymptomatic).
Thus, N95 respirators must only be used by a single wearer. To prevent inadvertent sharing of respirators, healthcare facilities should develop clearly written procedures to inform users to:
- Label containers used for storing respirators or label the respirator itself (e.g., on the straps(11)) between uses with the user’s name to reduce accidental usage of another person’s respirator.
Risks of Extended Use and Reuse of Respirators
Although extended use and reuse of respirators have the potential benefit of conserving limited supplies of disposable N95 respirators, concerns about these practices have been raised.
Some devices have not been FDA-cleared for reuse(21). Some manufacturers’ product user instructions recommend discard after each use (i.e., “for single use only”), while others allow reuse if permitted by infection control policy of the facility.(19)
The most significant risk is of contact transmission from touching the surface of the contaminated respirator. One study found that nurses averaged 25 touches per shift to their face, eyes, or N95 respirator during extended use.(15)
Contact transmission occurs through direct contact with others as well as through indirect contact by touching and contaminating surfaces that are then touched by other people.
Respiratory pathogens on the respirator surface can potentially be transferred by touch to the wearer’s hands and thus risk causing infection through subsequent touching of the mucous membranes of the face (i.e., self-inoculation).
While studies have shown that some respiratory pathogens (22-24) remain infectious on respirator surfaces for extended periods of time, in microbial transfer (25-27) and reaerosolization studies (28-32) more than ~99.8% have remained trapped on the respirator after handling or following simulated cough or sneeze.
Respirators might also become contaminated with other pathogens acquired from patients who are co-infected with common healthcare pathogens that have prolonged environmental survival (e.g., methicillin-resistant Staphylococcus aureas, vancomycin-resistant enterococci, Clostridium difficile, norovirus, etc.).
These organisms could then contaminate the hands of the wearer, and in turn be transmitted via self-inoculation or to others via direct or indirect contact transmission.
The risks of contact transmission when implementing extended use and reuse can be affected by the types of medical procedures being performed and the use of effective engineering and administrative controls, which affect how much a respirator becomes contaminated by droplet sprays or deposition of aerosolized particles.
For example, aerosol generating medical procedures such as bronchoscopies, sputum induction, or endotracheal intubation, are likely to cause higher levels of respirator surface contamination, while source control of patients (e.g. asking patients to wear facemasks), use of a face shield over the disposable N95 respirator, or use of engineering controls such as local exhaust ventilation are likely to reduce the levels of respirator surface contamination.(18)
While contact transmission caused by touching a contaminated respirator has been identified as the primary hazard of extended use and reuse of respirators, other concerns have been assessed, such as a reduction in the respirator’s ability to protect the wearer caused by rough handling or excessive reuse.(19, 20)
Extended use can cause additional discomfort to wearers from wearing the respirator longer than usual.(14, 15) However, this practice should be tolerable and should not be a health risk to medically cleared respirator users.(19)
Prioritize the use of N95 respirators and facemasks by activity type
The number of infectious particles required to cause an infection (infectious dose) is often uncertain or unknown for respiratory pathogens.
Further, there is often uncertainty about the influence of factors such as exposure duration and nature of clinical symptoms on the likelihood of infection transmission from person-to-person.
When facemasks must be used by HCP entering a patient care area, source control (i.e. masking of symptomatic patients) and maintaining distance from the patient are particularly important to reduce the risk of transmission.
This prioritization approach to conservation is intended to be used when N95 respirators are so limited that routinely practiced standards of care for all HCP wearing N95 respirators when caring for a COVID-19 patient are no longer possible.
N95 respirators beyond their manufacture-designated shelf life, when available, are preferable to use of facemasks.
The use of N95s or elastomeric respirators or PAPRs should be prioritized for HCP with the highest potential exposures including being present in the room during aerosol generating procedures performed on symptomatic persons.
Suggested facemask or respirator use, based upon distance from a patient with suspected or known COVID-19 and use of source control*
| Prioritize the use of N95 respirators and facemasks by activity type | |||
| HCP planned proximity to the case patient during encounter | Facemask or respirator determination | ||
| Patient masked for entire encounter (i.e., with source control) | Unmasked patient or mask needs to be removed for any period of time during the patient encounter | ||
| HCP will remain at greater than 6 feet from symptomatic patient | HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: no facemask or respirator | HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: no facemask or respirator | |
| HCP will be within 3 to 6 feet of symptomatic patient | HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: facemask | HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: facemask | |
| HCP will be within 3 feet of symptomatic patient, including providing direct patient care | Facemask | N95 respirator/ elastomeric /PAPR, based on availability | |
| HCP will be present in the room during aerosol generating procedures performed on symptomatic persons | N95 respirator/ elastomeric /PAPR, based on availability | N95 respirator/ elastomeric /PAPR, based on availability |
*Based on availability, organizations may require and/or individuals may voluntarily choose to utilize higher levels of protection
What is a respirator and what is a NIOSH-approved N-95 respirator?
A respirator is a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, or vapors.
The many types of respirators available include
(1) particulate respirators, which filter out airborne particles;
(2) “gas masks,” which filter out chemicals and gases;
(3) airline respirators, which use compressed air from a remote source; and
(4) self-contained breathing apparatus, which include their own air supply.
The category of particulate respirator can be further divided into
(1) disposable or filtering facepiece respirators, where the entire respirator is discarded when it becomes unsuitable for further use due to excessive resistance, sorbent exhaustion, or physical damage;
(2) reusable or elastomeric respirators, where the facepiece is cleaned and reused but the filter cartridges are discarded and replaced when they become unsuitable for further use; and
(3) powered air purifying respirators (PAPRs), where a battery-powered blower moves the air flow through the filters.
An N-95 respirator is one of nine types of disposable particulate respirators.
Particulate respirators are also known as “air-purifying respirators” because they protect by filtering particles out of the air as you breathe.
These respirators protect only against particles—not gases or vapors.
Since airborne biological agents such as bacteria or viruses are particles, they can be filtered by particulate respirators.
Respirators that filter out at least 95% of airborne particles during “worse case” testing using a “most-penetrating” sized particle are given a 95 rating.
Those that filter out at least 99% receive a “99” rating.
And those that filter at least 99.97% (essentially 100%) receive a “100” rating.
Respirators in this family are rated as N, R, or P for protection against oils.
This rating is important in industry because some industrial oils can degrade the filter performance so it doesn’t filter properly.
Respirators are rated “N,” if they are Not resistant to oil, “R” if somewhat Resistant to oil, and “P” if strongly resistant (oil Proof).
Thus, there are nine types of disposable particulate respirators:
- N-95, N-99, and N-100;
- R-95, R-99, and R-100;
- P-95, P-99, and P-100
NIOSH uses very high standards to test and approve respirators for occupational uses.
NIOSH-approved disposable respirators are marked with the manufacturer’s name, the part number (P/N), the protection provided by the filter (e.g., N-95), and “NIOSH.”
This information is printed on the facepiece, exhalation valve cover, or head straps.
View a listing of all NIOSH-approved disposable respirators.
If a disposable respirator does not have these markings and does not appear on one of these lists, it has not been certified by NIOSH.
NIOSH-Approved Particulate Filtering Facepiece Respirators
The NIOSH-approved products are listed by brand. Links to the manufacturers’ websites are provided as a courtesy to users and NIOSH is not responsible for the content of those pages.
Also included is the manufacturer’s phone number, product model number, approval number (84A-XXXX), an indication if the product has an exhalation valve, and the user donning instructions.
The manufacturer’s donning procedure and/or user instructions are also provided here as a courtesy to the user.
Manufacturers’ recommended procedures for performing a user seal check can be included in the donning procedures and/or user instructions as alternatives to the OSHA-specified procedures under the respiratory protection standard .
NIOSH does not evaluate the efficacy and reliability of any user seal check procedures, but OSHA will accept the manufacturer’s recommended procedures if the employer demonstrates those procedures are equally effective as those identified in the standard.
Each manufacturer is responsible for updating the links on their website and/or providing NIOSH with an updated or revised copy when changes are made.
The tables were created to provide easy access to a comprehensive listing of NIOSH-approved particulate filtering facepiece respirators and also to provide easy access to the donning process/user instructions.
The tables are not updated as frequently as the certified equipment list, which is the official NIOSH certification record.
Searching for a Product Using the Certified Equipment List
If you have a product that is not listed on the provided tables use the searchable certified equipment list.
Follow these steps to search for NIOSH-approved disposable particulate respirators:
- In For Protections Against section, select N95, N99, N100, R95, P95, or P100.
- In Facepiece Type section, select only Filtering Facepiece.
- Select View Results.
If your product is not listed, you should scroll through the list of “Private Label” products.
Filtering Facepiece Respirator (FFR) Labels
Individual filtering facepiece respirators are required to have the following markings:
- Name of approval holder/manufacturer business name, a registered trademark, or an easily understood abbreviation of the applicant/approval holder’s business name as recognized by NIOSH. When applicable, the name of the entity to which the FFR has been private labeled by the approval holder may replace the approval holder business name, registered trademark, or abbreviation of the approval holder business name as recognized by NIOSH.
- NIOSH in block letters or the NIOSH logo.
- NIOSH Testing and Certification approval number, e.g., TC-84A-XXXX.
- NIOSH filter series and filter efficiency level, e.g., N95, N99, N100, R95, P95, P99, P100.
- Model number or part number: The approval holder’s respirator model number or part number, represented by a series of numbers or alphanumeric markings, e.g., 8577 or 8577A.
NIOSH recommends the lot number and/or date of manufacture also be included, however, this is not required.
Sample of a generic filtering facepiece respirator with appropriate markings.
Filtering facepiece respirators that are private labeled are required to have the following statement on the packaging as a special S caution and limitation statement identified on the full label and located in the respirator user instructions:
- Marketed by xxxxxx (the private label company name).
- Produced by xxxxxx (the approval holder company name).
This private label related statement does not need to appear on the exterior surface of the respirator as part of the required name marking.
NIOSH-Approved N95 Particulate Filtering Facepiece Respirators
Manufacturers Listed Alphabetically
The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. This product filters at least 95% of airborne particles but is not resistant to oil.
This web page provides a table of NIOSH-approved N95 respirators, listed alphabetically by manufacturer. You can select a particular manufacturer by clicking on the first letter of their name on the index below.
There are some products that are approved by NIOSH as an N95 respirator and also cleared by the Food and Drug Administration (FDA) as a surgical mask.
These products are referred to as Surgical N95 Respirators.
For your convenience the Surgical N95 Respirators are indicated with the Model Number/Product Line in bold text followed by (FDA).
If you have a product you believe is NIOSH-approved and FDA-cleared that does not appear on this list, you will need to check with the FDA Center for Devices and Radiological Health at 1-800-638-2041 for validation of clearance.
- N95 –N95 – Filters at least 95% of airborne particles. Not resistant to oil.
- Surgical N95 – A NIOSH-approved N95 respirator that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask.
- N99 – Filters at least 99% of airborne particles. Not resistant to oil.
- N100 – Filters at least 99.97% of airborne particles. Not resistant to oil.
- R95 – Filters at least 95% of airborne particles. Somewhat resistant to oil.
- P95 – Filters at least 95% of airborne particles. Strongly resistant to oil.
- P99 – Filters at least 99% of airborne particles. Strongly resistant to oil.
- P100 – Filters at least 99.97% of airborne particles. Strongly resistant to oil.
Respirator Trusted-Source Information
Surgical N95 Respirators
This table of Surgical N95’s is provided as a courtesy. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041.
NIOSH-Approved N99 Particulate Filtering Facepiece Respirators
The N99 particulate filtering facepiece respirator filters at least 99% of airborne particles but is not resistant to oil.
Notes
| Notes | ||
| Notes | Company | Phone Number |
| *AD | Private label of Suzhou Sanical Protective Product Manufacturing Company, Ltdexternal icon | 86-512-66100068 |
| *E | Private label of Makrite Industries, Inc.external icon | 800-379-9929 86-21-5431-3117 (China) |
| *M | Private Label of Jinfuyu Industrial Company, Ltd.external icon | 886-2-2690-2271 |
| *Q | Private Label of Champak Enterprise Company, Ltd.external icon | 886-3-3808818 |
| *S | Private Label of Shanghai Dasheng Health Products Manufacture Company, Ltd.external icon | 86-21-5778-3126 |
NIOSH-Approved N100 Particulate Filtering Facepiece Respirators
The N100 particulate filtering facepiece respirator filters at least 99.97% of airborne particles but is not resistant to oil.
Notes
| Notes | ||
| Notes | Company | Phone Number |
| *A | Private label of Louis M. Gerson Company, Inc.external icon | 800-225-8623 |
| *AH | Private label of Air Filtration Solutions, Ltd.external icon | 44 (0) 1772 790820 (UK) |
| *M | Private Label of Jinfuyu Industrial Company, Ltd.external icon | 886-2-2690-2271 |
NIOSH-Approved R95 Particulate Filtering Facepiece Respirators
The R95 particulate filtering facepiece respirator filters at least 95% of airborne particles and is somewhat resistant to oil.
Notes
| Notes | ||
| Notes | Company | Phone Number |
| *A | Private label of Louis M. Gerson Company, Inc.external icon | 800-225-8623 |
| *E | Private label of Makrite Industries, Inc.external icon | 800-379-9929 86-21-5431-3117 (China) |
| *I | Private label of San Huei United Company, Ltd.external icon | 886-2-2683-0356 |
| *M | Private Label of Jinfuyu Industrial Company, Ltd.external icon | 886-2-2690-2271 |
| *N | Private Label of Fido Industrial Safety Masks Manufacturer Company, Ltd.external icon | 886-37-741471 |
NIOSH-Approved P95 Particulate Filtering Facepiece Respirators
The P95 particulate filtering facepiece respirator filters at least 95% of airborne particles and is strongly resistant to oil.
Notes
| Notes | ||
| Notes | Company | Phone Number |
| *A | Private label of Louis M. Gerson Company, Inc.external icon | 800-225-8623 |
| *AD | Private label of Suzhou Sanical Protective Product Manufacturing Company, Ltdexternal icon | 86-512-66100068 |
| *AF | Private label of Venus Safety & Healthexternal icon | 91-022-2769-2646 |
| *B | Private label of Aswan International Corporationexternal icon | 866-2-8369-2525 |
| *E | Private label of Makrite Industries, Inc.external icon | 800-379-9929 86-21-5431-3117 (China) |
NIOSH-Approved P99 Particulate Filtering Facepiece Respirators
The P99 particulate filtering facepiece respirator filters at least 99% of airborne particles and is strongly resistant to oil.
| NIOSH-Approved P99 Particulate Filtering Facepiece Respirators | ||||
| Supplier/Manufacturer and Contact Information | Model Number/ Product Line | Approval Number | Valve Yes/No | Manufacturer’s Donning Procedure User Instructions |
| Safe Life Corporation 858-794-3200 | T6000 | 84A-5184 Obsolete 11/2011 | No | T6000 Cdc-pdf[PDF – 144 KB]External |
| Safe Life Corporation 858-794-3200 | T6000V | 84A-5185 Obsolete 11/2011 | Yes | T6000V Cdc-pdf[PDF – 144 KB]External |
NIOSH-Approved P100 Particulate Filtering Facepiece Respirators
The P100 particulate filtering facepiece respirator filters at least 99.97% of airborne particles and is strongly resistant to oil.
Notes
| Notes | ||
| Notes | Company | Phone Number |
| *A | Private Label of Louis M. Gerson Company, Inc.external icon | 800-225-8623 |
| *AF | Private Label of Venus Safety & Healthexternal icon | 91-022-2769-2646 |
| *AJ | Private label of GVS Filter Technology UK, Ltd.external icon | 44 1524 847600 ext 262 (UK) |
| *M | Private Label of Jinfuyu Industrial Company, Ltd.external icon | 886-2-2690-2271 |
NIOSH also maintains a database of all NIOSH- approved respirators regardless of respirator type on the Certified Equipment List.
References
- Murray, M., J. Grant, E. Bryce, P. Chilton, and L. Forrester: Facial protective equipment, personnel, and pandemics: impact of the pandemic (H1N1) 2009 virus on personnel and use of facial protective equipment. Infection Control and Hospital Epidemiology 31(10): 1011-1016 (2010).
- Beckman, S., B. Materna, S. Goldmacher, J. Zipprich, M. D’Alessandro, D. Novak et al.: Evaluation of respiratory protection programs and practices in California hospitals during the 2009-2010 H1N1 influenza pandemic. American Journal of Infection Control 41(11): 1024-1031 (2013).
- Hines, L., E. Rees, and N. Pavelchak: Respiratory protection policies and practices among the health care workforce exposed to influenza in New York State: Evaluating emergency preparedness for the next pandemic. American Journal of Infection Control (2014).
- Srinivasan, A., D.B. Jernign, L. Liedtke, and L. Strausbaugh: Hospital preparedness for severe acute respiratory syndrome in the United States: views from a national survey of infectious diseases consultants. Clinical Infectious Diseases 39(2): 272-274 (2004).
- OSHA: “Enforcement procedures and scheduling for occupational exposure to tuberculosis.” [Online] Available at https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=1586external icon, 1996).
- Siegel, J.D., E. Rhinehart, M. Jackson, and L. Chiarello: “2007 Guideline for isolation precautions: preventing transmission of infectious agents in health care settings.” [Online] Available at https://www.cdc.gov/hicpac/pdf/isolation/isolation2007.pdfpdf icon, 2007).
- CDC: “Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care facilities.” [Online] Available at https://www.cdc.gov/mmwr/pdf/rr/rr4313.pdfpdf icon, 1994).
- Bollinger, N., J. Bryant, W. Ruch, J. Flesch, E. Petsonk, T. Hodous et al.: “TB Respiratory Protection Program in Health Care Facilities, Administrator’s Guide.” [Online] Available at https://www.cdc.gov/niosh/docs/99-143/, 1999).
- Jensen, P., L. Lambert, M. Iademarco, and R. Ridzon: “Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005.” [Online] Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm, 2005).
- CDC: “Questions and Answers Regarding Respiratory Protection For Preventing 2009 H1N1 Influenza Among Healthcare Personnel” [Online] Available at https://www.cdc.gov/h1n1flu/guidelines_infection_control_qa.htm, 2010).
- Rebmann, T., S. Alexander, T. Cain, B. Citarella, M. Cloughessy, and B. Coll “APIC position paper: extending the use and/or reusing respiratory protection in healthcare settings during disasters.” [Online] Available at http://www.apic.org/Resource_/TinyMceFileManager/Advocacy-PDFs/APIC_Position_Ext_the_Use_and_or_Reus_Resp_Prot_in_Hlthcare_Settings1209l.pdfpdf iconexternal icon, 2009).
- IOM: Reusability of facemasks during an influenza pandemic: facing the flu. Washington, D.C.: National Academies Press, 2006.
- Lin, C.S.: “FDA Regulation of Surgical Masks and Respirators.” [Online] Available at http://www.iom.edu/~/media/Files/Activity Files/PublicHealth/ReusableFluMasks/FDApresentation12306.ashxexternal icon, 2006).
- Radonovich Jr, L.J., J. Cheng, B.V. Shenal, M. Hodgson, and B.S. Bender: Respirator tolerance in health care workers. JAMA: The Journal of the American Medical Association 301(1): 36-38 (2009).
- Rebmann, T., R. Carrico, and J. Wang: Physiologic and other effects and compliance with long-term respirator use among medical intensive care unit nurses. American Journal of Infection Control 41(12): 1218-1223 (2013).
- CDC: “Sequence for donning personal protective equipment PPE/Sequence for removing personal protective equipment.” [Online] Available at https://www.cdc.gov/HAI/pdfs/ppe/ppeposter148.pdfpdf icon
- Roberge, R.J.: Effect of surgical masks worn concurrently over N95 filtering facepiece respirators: extended service life versus increased user burden. Journal of Public Health Management and Practice : JPHMP 14(2): E19-26 (2008).
- Fisher, E.M., J.D. Noti, W.G. Lindsley, F.M. Blachere, and R.E. Shaffer: Validation and Application of Models to Predict Facemask Influenza Contamination in Healthcare Settings. Risk Analysis in press(2014).
- Fisher, E.M., and R.E. Shaffer: Considerations for Recommending Extended Use and Limited Reuse of Filtering Facepiece Respirators in Healthcare Settings Journal of Occupational and Environmental Hygiene: (in press) (2014).
- Bergman, M.S., D.J. Viscusi, Z. Zhuang, A.J. Palmiero, J.B. Powell, and R.E. Shaffer: Impact of multiple consecutive donnings on filtering facepiece respirator fit. American Journal of Infection Control 40(4): 375-380 (2012).
- FDA: “510(k) Premarket Notification.” [Online] Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfmexternal icon, 2014).
- Casanova, L., W.A. Rutala, D.J. Weber, and M.D. Sobsey: Coronavirus survival on healthcare personal protective equipment. Infection Control and Hospital Epidemiology 31(5): 560-561 (2010).
- Coulliette, A., K. Perry, J. Edwards, and J. Noble-Wang: Persistence of the 2009 Pandemic Influenza A (H1N1) Virus on N95 Respirators. Applied and Environmental Microbiology 79(7): 2148-2155 (2013).
- Fisher, E.M., and R.E. Shaffer: Survival of bacteriophage MS2 on filtering facepiece respirator coupons. Applied Biosafety: Journal of the American Biological Safety Association 15(2): 71 (2010).
- Lopez, G.U., C.P. Gerba, A.H. Tamimi, M. Kitajima, S.L. Maxwell, and J.B. Rose: Transfer Efficiency of Bacteria and Viruses from Porous and Nonporous Fomites to Fingers under Different Relative Humidity Conditions. Applied and Environmental Microbiology 79(18): 5728-5734 (2013).
- Fisher, E.M., C.M. Ylitalo, N. Stepanova, and R.E. Shaffer: Assessing Filtering Facepiece Respirator Contamination During Patient Care in Flu Season: Experimental and Modeling Approaches. In ISRP — Sixteenth International Conference:A Global View on Respiratory Protection. Boston, 2012.
- Rusin, P., S. Maxwell, and C. Gerba: Comparative surface-to-hand and fingertip-to-mouth transfer efficiency of gram-positive bacteria, gram-negative bacteria, and phage. Journal of Applied Microbiology 93(4): 585-592 (2002).
- Fisher, E.M., A.W. Richardson, S.D. Harpest, K.C. Hofacre, and R.E. Shaffer: Reaerosolization of MS2 bacteriophage from an N95 filtering facepiece respirator by simulated coughing. Annals of Occupational Hygiene 56(3): 315-325 (2012).
- Birkner, J.S., D. Fung, W.C. Hinds, and N.J. Kennedy: Particle release from respirators, part I: determination of the effect of particle size, drop height, and load. Journal of Occupational and Environmental Hygiene 8(1): 1-9 (2011).
- Kennedy, N.J., and W.C. Hinds: Release of simulated anthrax particles from disposable respirators. Journal of Occupational and Environmental Hygiene1(1): 7-10 (2004).
- Qian, Y., K. Willeke, S.A. Grinshpun, and J. Donnelly: Performance of N95 respirators: reaerosolization of bacteria and solid particles. American Industrial Hygiene Association Journal 58(12): 876-880 (1997).
- Willeke, K., and Y. Qian: Tuberculosis control through respirator wear: performance of National Institute for Occupational Safety and Health-regulated respirators. American Journal of Infection Control 26(2): 139-142 (1998).
[…] What no one tells you about the COVID-19 masks: Classification –… […]