Tests during the pandemic have shown many imported masks fall well short of N95 filtration standards.
Federal officials withdrew approval for more than 60 manufacturers in China to export N95-style masks to the U.S. after finding what they said were a large number of low-quality products from those companies. The WSJ reported.
The US. Food and Drug Administration said that it had cut the number of mask makers in China approved to make N95-style masks for use in the U.S. to 14, from around 80.
That reversed a decision to allow the emergency use of dozens of N-95 face masks made in China, after government testing found many didn’t work properly.
The agency had authorized use of the masks to help address shortages of personal protective equipment, on the condition that their effectiveness was verified by independent testing labs. That policy, put in place April 3, is being reversed based on testing by the National Institute for Occupational Safety and Health that found many masks from China failed to meet filtration standards.
Dow Jones earlier reported that the FDA was pulling the authorization.
The masks “may not provide consistent and adequate respiratory protection to health care personnel exposed to Covid-19,” the FDA said in a letter to health-care providers Thursday.
Bloomberg reported that, the agency revoked clearance for about 60 face-mask makers made in China, leaving 14 firms authorized mainly because they met other criteria to show FDA their products work. The FDA said that it is also increasing surveillance of masks imported from China and will subject shipments to random testing.
Compiling by Vietnam Insider staff.
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