Your FDA registration means nothing to me

Chinese Factory: We made a mask. We claim a Substantial Equivalence to this predicated mask XYZ. 

FDA: OK cool. Here’s your 510(k) pre-market registration

That’s literally all it means to have your KN95 mask FDA registration.  Of most importance is to note that FDA registration, FDA clearance and FDA approval are VERY, VERY different things. So just because some vender waves some PDF of FDA registration, does not mean the FDA has done ANYTHING to prove this mask is any good. It doesn’t necessarily mean it is bad either.

“Please note that FDA does not typically perform 510(k) pre-clearance facility inspections”

Did you catch that? It’s not like the FDA isn’t hopping on a plane to China in the middle of a pandemic to make sure that Aoxing Audio and Visual company is making their mask correctly. 

It is very easy to copy and paste the FDA logo onto some packaging. That’s about all it takes. That and a fake PDF and voila. The FDA logo shouldn’t be on there in the first place. My hypothesis is that an FDA logo on your box or mask has a high correlation with being a counterfeit mask.

The FDA really has nothing to do with filtration in the first place. NIOSH, which is a division of the CDC, certifies a N95 and gives its approval. Only if it is a surgical N95, made to be used in the operating room, is it sent to the FDA. There it is tested for fluid penetrance as a surgical mask. If it passes, it is FDA cleared to be used as a surgical mask as well.

If you’re looking for a list of FDA emergency use authorized masks, it is here. It is a very short list. And today the FDA made it even shorter, citing inadequacies in filtration of some. They are authorized, because the FDA has not cleared or approved these, merely allowed them. The CDC has started to test some of their filtration, which is why some were removed.

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