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Tue Mar 31, 2020, 06:01 AM

Alternative to the N95 mask the FDA refuses to allow it in [View all]

The KN95 mask is a Chinese alternative to the scarce N95 mask, but the FDA refuses to allow it into the country.

By Ken Bensinger

March 29, 2020

As hospitals around the country desperately seek N95 respirator masks to protect health care workers treating COVID-19 patients, the federal government has blocked imports of what might be the world’s most abundant alternative.

That mask is designed to filter out at least 95% of particles that are 0.3 microns or larger in size — the same measure used for the scarce N95 mask. Like the N95, it fits closely around the nose and mouth, creating a seal that decreases the risk of infection. And the Centers for Disease Control has said it’s as effective as N95, which is certified under US testing standards. But this second type of mask, called the KN95, complies with slightly different norms and is made in factories that have not been certified by the US government.

By law, masks, along with most medical devices, can’t be imported or sold in the United States without the Food and Drug Administration’s say-so. Last week, to ease the national shortfall of protective gear, the FDA issued an emergency authorization for non-N95 respirators that had been certified by five foreign countries as well as the European Union. It conspicuously left the KN95 masks out of the emergency authorization.



https://www.buzzfeednews.com/article/kenbensinger/coronavirus-kn95-masks-us-wont-import-china



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