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U.S. regulators and state officials are finding a significant number of imported N95-style masks fall short of certification standards, complicating the response to the coronavirus crisis and potentially putting some front-line workers at greater risk.
Recent tests by the National Institute for Occupational Safety and Health found that about 60 percent of 67 different types of imported masks tested allowed in more tiny particles in at least one sample than U.S. standards normally permit.
One mask that Niosh tested, sold in packaging bearing unauthorized Food and Drug Administration logos, filtered out as little as 35 percent of particles. Another, marked KN95, a Chinese standard similar to N95, had one sample test below 15 percent, far short of the 95 percent it advertised, Niosh said. KN95 and N95 both refer to standards that call for masks to block 95 percent of very small particles.
The Niosh tests, combined with recalls and additional testing from multiple states, show that millions of substandard masks have been imported from China and other countries as the need for protective gear for workers confronting the pandemic has skyrocketed.
“Niosh is very concerned about this issue,” the institute said in a statement to The Wall Street Journal. Niosh, part of the Centers for Disease Control and Prevention, used 10 samples from each of the 67 mask types in its tests.
With domestic production and stockpiles falling far short of demand, the tests suggest a high risk that hospitals, local authorities and companies are in many cases paying steep prices for substandard medical gear of uncertain provenance.
Another issue identified by Niosh: Most of the samples it tested used ear loops to secure them to the head, while all Niosh-approved masks have headbands to ensure a tighter fit. A tight fit is important to keep out tiny droplets that may contain the coronavirus, especially because N95s are typically used by health-care workers facing direct exposure.