Is your N95-style mask failing you? Lab tests show some falling way short of filtration standards
Experts say avoid resellers and consider the FDA logo a red flag
UPDATE: This story was originally published in April 2021. As of December 2021, Public Health Agency of Canada guidance has changed. It now recommends wearing the best quality mask possible, including N95 and KN95 respirators.
As more dangerous variants of the coronavirus spread, many Canadians are looking to upgrade their mask.
That has some people reaching for N95-style respirators. When tested against particles that are approximately 0.3 microns in size, N95 particulate respirator filters are certified to be at least 95 per cent efficient.
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When shopping online and in stores, consumers are most likely to find the international equivalents of the coveted N95, as these masks are still generally not available in stores.
The imported equivalents include the KN95 respirator, which meets the Chinese standard of 95 per cent filtration efficiency and the KF94, which meets the Korean standard of 94 per cent filtration efficiency.
However, as demand for these masks has grown, so has the presence of counterfeits and poor-quality respirators in Canadian stores.
To find out how much Canadians can trust what they're buying, CBC's Marketplace tested 14 KN95 and KF94 respirator brands purchased from Amazon and big box stores.
Three masks from each brand were tested at a lab at the University of Toronto's Dalla Lana School of Public Health to see if they meet their filtration efficiency claims. Half failed.
"As a consumer in Canada right now, you can't be confident of going to a reputable vendor, buying a pack of masks with a stamp that says KN95 or N95 or KF94, and have really any confidence that those masks meet that standard, and that's a huge worry from me as an academic, but also as a consumer," said James Scott, a professor of occupational and environmental health who oversaw the testing.
Marketplace shared the failing results with the stores and the manufacturers who made them. Some stores have since removed the products or say they are investigating further. Others maintain they are following regulatory guidelines.
What do the test results tell you?
While some masks tested well below the 95 per cent filtration standard threshold, others failed by just a percentage point or two. So how much do the results matter?
According to emergency room physician Dr. Jay Park of San Diego, Calif., it depends on who is using the mask and the level of protection they need or want.
Since the beginning of the pandemic, Park has been working to verify the authenticity and quality of N95-style respirators destined for hospitals. He has since shared his expertise and compiled tips on what average consumers can look for when buying these masks.
"The respirators on the low end of the test results may provide a similar level of protection to many cloth masks,'' said Park.
WATCH | We tested 14 types of KN95 and KF94 masks. Here's what we found:
As for the masks that came in just a percentage point or two below the standard, he said they can still be used.
"If you are a consumer and you're just using this to go shopping or do low-risk activities, then yes, your testing results do show that it protects you better than cloth masks. You don't have to throw them out. I think that you just need to be informed that these do not meet KN95, 95 per cent filtration standards."
Scott said that the consequence of a failing mask could be greater for those at higher risk of exposure or more severe disease.
"They matter for [health-care] workers and to a similar extent they matter for members of the public who have very specific susceptibilities where they need to go that extra distance to [protect] themselves from people in the environment."
Should I be wearing a KN95 or KF94 respirator?
Experts agree the best protection against COVID-19 is to limit contact with others by staying home and physical distancing.
Park advises that those at higher risk choose the best protection available to them.
"If you're telling me that you're riding the subway or you need to ride public transportation, or you're a teacher and you're working in an indoor classroom full of children that typically don't show signs and symptoms of COVID-19, then yes, I believe you should get the highest protection possible."
What are some tips to avoid poor-quality or counterfeit respirator masks?
1. Cut out resellers
Park advises to avoid resellers. Instead, he said to buy directly from the source or companies with a history in selling personal protective equipment (PPE).
These companies, he said, are more likely to have a relationship with a reputable supplier. Some manufacturers also sell directly to consumers, including Canadian companies that have recently been ramping up production of N95-style respirators.
2: Avoid the FDA logo
Health Canada and the United States Food and Drug Administration had temporarily authorized the sale of some KN95 and KF94 respirators during the pandemic. However, even authorized respirators are not allowed to use the FDA logo.
"The FDA logo is for the official use of the U.S. Food and Drug Administration (FDA) and not for use on private sector materials," the FDA website says.
3: Be wary of unmarked packaging or an unknown manufacturer
Some of the products Marketplace purchased arrived in unmarked packaging or in boxes that did not include the manufacturer's name and address. That's another red flag, said Park.
"You don't want to buy something that is potentially a medical product and not know who the manufacturer is for you to be able to trace back and say OK, this is who made it and I can look up their registration or certification online," he said.
4: Check Health Canada, the FDA and CDC websites
Health Canada has a list of authorized medical devices for uses related to COVID-19. You can check whether your mask is among them. However, only respirators authorized under the interim order introduced after COVID-19 struck are on this list.
The FDA also has a list of KN95s and other imported respirators that have been authorized for use.
You can also check the Centers for Disease Control and Prevention's list of Counterfeit Respirators/Misrepresentation of NIOSH-Approval.
Park has also created a PPE authentication site that aggregates the data on masks that are authorized for sale or recalled in Canada, the U.S and Europe.
What do the companies say about the results?
Marketplace reached out to the stores and retailers selling the KN95 and KF94 respirators that failed the filtration test. Here is how they responded:
Well.ca, whose masks tested among the lowest, did not respond directly to the test results. Instead, it directed Marketplace to contact the manufacturer. That information was not listed on the product packaging and Well.ca did not provide it when asked.
Amazon said that it verifies that all masks on their sites are legitimate. It said that there are "bad actors" that purposely evade their protections and that they removed the products that failed. The seller of the Seal Goods mask on Amazon said the ones purchased by Marketplace could be counterfeit.
Walmart also removed the mask that failed from its website. It said it does not permit the sale of KN95s and that the product purchased should never have been for sale. They did not explain how this mask and other KN95s ended up on their site.
Home Depot and Home Hardware said they follow regulatory standards. Home Depot said that it is investigating further.
Marketplace also shared its results with Health Canada, which said it "monitors information about counterfeit, fraudulent and unauthorized COVID-19 devices, including personal protective equipment. Devices that are confirmed to be counterfeit or unauthorized are removed from the market and are not permitted to be sold in Canada."
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