FDA to allow imports of KN95 masks from China

[url=https://www.z2u.com/mask/items-3-9886][b]N95 Mask[/b][/url] In a move that could significantly ease national shortages of personal protective equipment a top Food and Drug Administration official said Thursday that the agency will not block imports of KN95 respirator masks a Chinese equivalent to the N95 masks needed by health care workers on the front lines of the coronavirus epidemic.

The masks have been described as the Chinese equivalent of an N95 mask which U.S. health care workers use to protect themselves from airborne bacteria and viruses. Though they are allowing imports of the KN95 mask the product is not FDA-approved meaning those who use it do so without legal protections.

But the FDA’s emergency authorization omitted the KN95 mask — despite the fact that the Centers for Disease Control and Prevention had previously included it on a list of “suitable alternatives” to the N95 mask.

"Because of this the FDA generally would not object to the importation and use of KN95 masks without an EUA," an FDA official told The Hill. "Although not required [url=https://www.z2u.com/mask/items-3-9886][b]FFP3 Mask[/b][/url] if a KN95 mask does not have an EUA importers may want to take appropriate steps to verify the authenticity of these products. The FDA is ready and available to engage with importers to minimize disruptions during the importing process."

A BuzzFeed News story about the KN95 published earlier this week led to demands from members of the public experts in the import business and even a member of Congress that the FDA clear the path for KN95 masks. A KN95 petition launched early this week has to date gained more than 2,500 signatures.

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