It’s safe to say that mask terminology is pretty new to most of us. So when we’re introduced to mask names like “N95” and “K95”, there’s no doubt that the question, What’s the difference? arises for many of us.
What’s the difference… and what’s the same?
In a sentence, the N95 mask is the American standard, and the KN95 is the Chinese standard. Both masks filter out the same amount of particles—95%, to be exact.
So… what’s the difference then? And why do we mostly hear about the N95 mask here in Canada?
Firstly, the Chinese standard states a requirement for what is called a fit test. These tests seek to ensure the best possible fit of the mask around your face, as well as the efficiency of the mask to filter out particles on your unique face.
While fit tests aren’t part of the United States’ respiratory mask standards, they are still recognized as an important and incredibly useful tool throughout the country. Hospitals, doctors’ offices, and other companies may choose to require or recommend fit tests of their employees, but this is at the discretion of the organization.
And it’s much the same for Canada. Both the N95 and KN95 masks are considered Class 1 medical devices throughout Canada; the N95 is simply the Canadian standard. Both are manufactured here in Canada, too, by companies like Aegis Health and Via Choice!
For a detailed understanding of other minute differences between the KN95 and N95 masks, refer to this chart:
So… why does it matter?
Since the start of the pandemic, the National Institute for Occupational Safety and Health (NIOSH) has noted a plethora of counterfeit and substandard masks for sale and distribution. In order to purchase an effective N95 or KN95 mask, check to see it’s NIOSH-certified by entering the approval number in the NIOSH database. If your mask is authentic, the approval number will be easily located on the mask itself.
If your mask is found to be unauthentic, the CDC recommends that you stop wearing it, and purchase one that is.
What does Health Canada say?
In Canada, Commercial, Surgical, and Industrial respirators have been categorized to identify standard mask regulations.
“Commercial respirators are regulated under the Food and Drugs Act as Class I medical devices in Canada if they're manufactured, sold, or represented to reduce the risk of, or prevent the user from, contracting a disease such as COVID-19. All surgical respirators are Class I medical devices. Commercial respirators would be considered Class I medical devices if they either:
- include any drugs, biologics or anti-microbial/anti-viral agents
- claim FDA, CE or other regulatory approval as a medical device
- make anti-viral (virucidal) or anti-bacterial (bactericidal) claims
- don't have exhalation valves in the absence of industrial use indication
- are labelled or promoted for use to protect the wearer from COVID-19 or other infectious particles
- are labelled, promoted or represented as meeting a recognized filtration efficiency rating (for example, N95, 95PFE, KN95) without a clearly stated industrial purpose or
- are labelled with an appropriate international standard without a clearly stated industrial purpose”*
Note: A commercial respirator labelled with the statement "not for medical use" may still be classified as a medical device if it has any of the listed characteristics, medical claims, or representations.
- A copy of the Medical Device Establishment License (MDEL), when applicable
- A Natural Product Number (NPN) for alcohol-based items, such as hand sanitizer
- Copies of certifications and testing results for products, when applicable
- Evidence of insurance
- References or a demonstrated track record
Keep asking the important questions
Both the KN95 and N95 masks, when authentic and thus approved by the NIOSH, are excellent respirators for protection against COVID-19. Refer to this article to know how to spot the counterfeits, and continue making informed purchases for safe and effective PPE.