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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.
The omission was all the more startling because in late February the Centers for Disease Control and Prevention said that KN95 masks were one of numerous “suitable alternatives” to N95 masks “when supplies are short.”
The FDA did not respond to multiple requests for comment.
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.
Allowing the importation and use of KN95 could help to greatly alleviate the scarcity.
“The KN95 masks are far more readily available,” said Bob Tilton, who owns a New Jersey–based cosmetics packaging importer and earlier this month decided to use his familiarity with Chinese supply chains to bring in masks and other personal protective equipment to sell to hospitals. “The N95s are much harder to grab.”
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.
Meanwhile, masks made under the newly permitted US standards — Australia, Brazil, Japan, Korea, Mexico, and the EU — are not made in as great quantities as the N95 or KN95, according to industry experts.
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According to 3M, the world’s largest mask manufacturer, the KN95 is “equivalent” and “can be expected to function very similar” to the N95 mask. That opinion was echoed on Feb. 29 by the CDC, which said the KN95 is one of seven foreign-certified respirators “expected to provide protection to workers.”