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The FDA Reversed Itself And Has Now Approved KN95 Masks For Emergency Use

The FDA Reversed Itself And Has Now Approved KN95 Masks For Emergency Use

The Food and Drug Administration said Friday that it would formally authorize the use of KN95 masks by health care workers fighting coronavirus, a shift in policy on the Chinese-made masks prompted by the urgent need for protective equipment.


The announcement marks a significant reversal. Last week, the FDA had excluded the devices from a list of foreign-certified masks it said could be used as acceptable substitutes for the highly sought-after N95 respirator mask.


The change follows reports by BuzzFeed News about widespread uncertainty regarding KN95 masks, which appear to be far more available than N95 masks and have been recommended by the Centers for Disease Control and Prevention as a “suitable alternative” to their American counterparts. Across the country, doctors, nurses, and other health care workers say they are desperately short of masks and other protective equipment, putting them at risk of infection as they treat patients flooding into hospitals with symptoms of COVID-19. Under a new emergency use authorization, the FDA said that the KN95 devices, which are similar to scarce N95 masks, could be imported into the country and are “eligible for authorization.” It stopped short of giving blanket approval for all of the KN95 respirators — which are certified under Chinese rather than US health standards — noting that it would only approve use of those that meet certain criteria, “including evidence demonstrating that the respirator is authentic.”


Click Here for a comparison of N95 and KN95 Masks

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