First, examine the packaging of the FFP2 KN95 respirators. Take note of the following:
Everything looks great!
Next, you can dig in and find out if it has been accepted for use by the FDA. Just navigate to the FDA Certified Supplier Lookup. Then type in the manufacturer’s name. Typically you should be able to find them using the “owner/operator number” search field on the right.
Next, view the company data and face mask registration if desired.
Finally, you can look up their business license number to make sure it is real. You will need a page translator plug-in because it is a Chinese business. Click some of the links that appear to see instances where their business license number has been published.
The mask packaging is also required to publish the intended use and other instructions on its packaging.
KN95 mask manufacturers need to have proper descriptive material. In addition to instructions for use, there are often package inserts.
Descriptive printed materials are prohibited from representing, claiming, or suggesting that the respirator product is safe or effective for the prevention of COVID-19. So if any package inserts or labels mention COVID-19 specifically, that may be a red flag.
These KN95 masks provided by HealthcareUnlocked.com have packaging that would be expected for a regulatory-compliant face mask.
When you go to open the mask, you’ll notice that it is sealed above the “zip-lock.” This is tamper-evident sealing. It tells you the package has not been opened since being manufactured.
This seal should always be in place when present. Mask packaging may vary, but the presence of the seal is a good mark of quality.
Disposable non-NIOSH-approved respirators, like KN95 masks, are eligible for authorization under the FDA’s Emergency Use Act (EUA). You may notice that the “FDA” logo is not on these masks. They should have the “CE” emblem instead because they are produced under Europen standards.
This mask appears to meet all of the FDA requirements for accepted CE-produced masks. It is in the FDA database, has proper labeling, and has proper packaging.
You can also see that the mask itself is properly marked:
There are two main tests you can do at home to check the quality and fit of your KN95 mask. These are The Lighter Test and The Water Test.
If you need the protection level offered by a KN95 mask, you need to be sure it will give the protection it claims. Whether you are a healthcare worker, a household member of a COVID-19 patient, or an immune-compromised individual, protection matters.
Healthcare Unlocked KN-95 masks have been used in this pictorial. However, the same procedures and requirements can be applied to any KN95 mask. Counterfeit KN95 masks are a growing problem, so be sure you are getting a real vs fake KN95 mask.