When looking at masks, it can be overwhelming and confusing when trying to discern which mask would be best suited to your particular circumstances. N95 and P2 masks are both half-face particulate respirators designed to filter out over 94% of airborne particles. They are specifically engineered to provide protection against biologically active particles, including those emitted by the COVID-19 virus. At Fit Test Australia, we always aim to educate and inform, and welcome questions so that we know our clients are making choices to support their lifestyles and circumstances. One question we receive frequently is “is a P2 mask the same as an N95”.
So Is a P2 Mask the Same as an N95 Mask?
P2/N95 masks are designed to filter airborne particles.All respirators are designed for specific jobs, tasks, and/or industries. In Australia, the distinction difference between a P2 and N95 respirator merely comes down to the technical specifications, which can be tied back to regional standards.
Because they adhere to different standards, there are distinctions between P2/N95 masks.
What is the difference between P2 and N95 Masks?
An N95 is more of an American-style respirator made to comply with the National Institute for Occupational Safety and Health (NIOSH) in line with 42 CFR Part 84. This standard governs the stringent filtering efficiency and ensures the accuracy of at least 95% filtration.
The P2 respirator is made in accordance with the Australian/New Zealand Standard AS/NZS 1716:2012 complying with the regulations and standards set for respiratory protective devices. A P2 must adhere to specific testing and certification criteria including filtration efficiency, with an accuracy of at least 94%.
Furthermore, P2 masks must undergo human fit testing for certification and approval, a requirement absent in N95 masks under NiOSH standards.
Under AS/NZS1716 standards, P2 masks must feature 'exhalation resistance' for easier breathing, with additional CO2 clearance testing mandated in Australia to prevent buildup within the respirator. These tests are not mandatory for N95 masks.
P2/N95 masks are therefore very similar in functionality, but clearly a P2 mask is not the same as an N95 mask.
Differences Between Three Respirator Models
You can read more about the above 3M sheet here. The sheet demonstrates just one example of a P2 not suitable for healthcare.
N95 Respirator (United States Standard):
Filter Performance:
The N95 respirator is designed to filter a minimum of 95% of airborne particles, including those as small as 0.3 micrometres.
Fluid Protection:
By design, an N95 provides a higher level of fluid resistance, making it a suitable option for healthcare environments where exposure to bodily fluids is a concern.
Fit Testing:
Proper fit is paramount for N95 respirators to provide their full level of intended protection, maximising both filtration efficiency and fluid protection.
P2 Respirator (Australian/New Zealand Standard):
Filter Performance:
P2 respirators are certified to filter out at least 94% of airborne particles, including those measuring 0.3 micrometres or larger.
Fluid Protection in Healthcare:
While P2 respirators may offer adequate filtration, a P2 typically only has a level 2 fluid rating. In healthcare settings, a higher fluid protection of a level 3 grade is required. To be eligible for the healthcare sector, a P2 respirator must also meet the stringent criteria set by the Therapeutic Goods Administration (TGA).
TGA Approval:
While part of the Australian Government Department of Health, the TGA plays a pivotal role responsible for regulating therapeutic goods for a range of products, including respirators. Any respirator intended for healthcare use must undergo stringent TGA approval, ensuring it meets the necessary standards for both filtration and .
Fit Testing:
Proper fit is paramount for P2 respirators to provide their full level of intended protection, maximising both filtration efficiency and fluid protection.
TGA Approval Broken Down
Face mask regulation
Non-sterile face masks (including respirators) that are intended, by their manufacturer, to prevent the transmission of diseases between people, or are intended to be used in a healthcare environment, are medical devices (see the Therapeutic Goods (Specified Articles) Instrument 2020- external site). They are regulated by the TGA under the Therapeutic Goods Act 1989- external site. - TGA
Face masks that are not regulated by the TGA
"Face masks which are non-sterile and are not intended by their manufacturer to be used for the prevention of the transmission of diseases between people, are excluded from regulation by the TGA under the Therapeutic Goods (Excluded Goods) Determination 2018." - TGA
What Does This All Mean?
By design, an everyday P2 manufactured for industry (as mentioned above) has not undergone the stringent process required to be deemed a 'medical or surgical respirator" and will not be approved for the healthcare sector.
All P2 masks found in healthcare have to undergo stringent processes to meet approvals and standards and be deemed a 'medical or surgical respirator' labeling them 'Hospital or Medical Grade', and they must again be approved by the TGA to end up in the healthcare sector.
While not specifically mentioned in the ISO 22609 or TGA standards, healthcare-grade masks, including P2 masks, are generally required to meet high standards for Bacterial Filtration Efficiency (BFE) and Particulate Filtration Efficiency (PFE).
This is why the classic 3M 9320A+ particulate respirator was used within the healthcare sector until it was recognised that it did not meet TGA approval.
Safety Data Sheet - 3M™ Aura™ 9320A+ Particulate Respirator, FFP2
The 3M 1870+ and 3M 1860 particulate respirators by design are intended for healthcare. These masks also have the Bacterial Filtration Efficiency (BFE) > 99% according to ASTM F2101and meets CDC guidelines for Mycobacterium tuberculosis exposure control.
Safety Data Sheet - 3M™ Aura™ Health Care Particulate Respirator and Surgical Mask 1870+, N95 and 3M™ Health Care Particulate Respirator and Surgical Mask 1860, N95.
The Softmed A-Med, Industree Trident, Care Essential range, and Detmold masks are all proudly Australian P2 respirators that would not be found in hospitals if they did not undergo the above approvals and standards mentioned deeming them healthcare grade and TGA approved.
These P2 respirators have successfully reached their target market.
Without such approvals you would and most likely still will find these in the industrial sector and more likely in the back of a dirty ute tray.
On the flip side, there are hundreds of P2 masks that will not be found in healthcare.
Common Approvals and Standards N95
NIOSH approved N95 respirator
Meets NIOSH 42 CFR 84 N95 requirements for a minimum 95% filtration efficiency against solid and liquid aerosols that do not contain oil.
NIOSH approval number: TC-84A-0006
FDA cleared for use as a surgical mask
Health Canada Class 1 medical device
Bacterial Filtration Efficiency F2101 >99% BFE
OSHA Assigned Protection Factor (APF) 10
Australia TGA approved
Common Approvals and Standards P2
Additional Technical Considerations For A P2 And N95 Respirator
Breathability:
Breathability is a key component considered when designing both the N95 and P2 respirators. The choice of materials and filter media influences assist with meeting effective filtration and breathability for the wearer.
Valve Options:
Some respirators may feature exhalation valves designed to enhance breathability especially in warmer weather. However, many healthcare facilities have steered away from valved respirators. As a result, you will not see valved respirators within healthcare facilities.
Use in Healthcare Settings:
N95’s typically have a higher fluid protection factor and are commonly used in healthcare settings across the United States. These respirators have been adopted here in Australia, with an N95 being a common choice in our healthcare sector as well. The Australian P2 respirator is prevalent in various industries and more recently, in healthcare. If a P2 respirator has an intent on infiltrating the healthcare sector, it must meet the elevated level 3 fluid resistance standards having specifications to be TGA approved.
Why Does Mask Fit Matter?
The effectiveness of a mask hinges on its fit. Any gaps along the sides or under the chin can permit air and droplets to circumvent the filtration material. It's crucial to ensure the mask is snugly adjusted to cover both the mouth and nose entirely. A properly fitting mask remains securely in place over the nose and cheeks, and even a standard mask can prevent eyeglasses from fogging up if it fits well. We recommend an annual mask fit test to ensure your protective equipment is performing to its best ability.
So Is a P2 Mask the Same as an N95?
The P2 and N95 are both designed to provide effective respiratory protection against airborne particles. The country of origin determines the different standards and certifications to which they are designed. Wearers must always follow manufacturer recommendations when being worn and undergo a fit test to optimise the respirator's full level of intended protection.
If you require additional information, you can contact Fit Test Australia Pty Ltd via email - info@fta.net.
Your health and safety is our business.
Call: 0403 064 064
Email: info@fta.net.au
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