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US Won't Allow Imports of Millions of KN95 Masks from China
Published on: 2020-04-01
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kn95KN95 Masks

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.

Medics prepare to transfer a patient on a stretcher to an ambulance at the Life Care Center of KirklandMedics prepare to transfer a patient on a stretcher to an ambulance at the Life Care Center of Kirkland

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.

America has been testing patients for coronavirus at a much lower rate than most other countriesAmerica has been testing patients for coronavirus at a much lower rate than most other countries
 

A significant majority of all respirator masks, including both the N95 and KN95, are manufactured in China. During the height of that country’s outbreak, China restricted exports of virtually all respirator masks, keeping them for domestic use. As that country’s infection numbers have slowed it has eased those restrictions, but now the US must compete with dozens of other countries desperate to acquire masks.

20200303 USA Medics and other healthcare workers transfer a patient on a stretcher to an ambulance at the Life Care Center of Kirkland linked to the two of three confirmed coronavirus cases in the stateMedics and other healthcare workers transfer a patient on a stretcher to an ambulance at the Life Care Center of Kirkland, linked to the two of three confirmed coronavirus cases in the state

Yet without the FDA’s seal of approval, importers are hesitant to order KN95 masks because they worry they’ll get held up at customs. Many hospitals are refusing to accept them, even as free donations, because they fear legal liability should a health care worker get ill while using a nonpermitted device.
 

Under ordinary circumstances, N95 masks — which are certified by the National Institute for Occupational Safety and Health — are abundant, available at hardware stores and pharmacies for around $1 apiece and for as little as 35 cents apiece wholesale. But in just two months, the coronavirus pandemic has depleted the world’s supply, creating a gray market that has driven prices for a single mask as high as $12 or more. That, in turn, has opened the door to unscrupulous actors running internet scams that take payment for N95 masks they never deliver, and to others selling counterfeit or mislabeled N95 masks, which could put health care workers at serious risk of infection.

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