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U.S. Pulls Authorization for Use of Face Masks Made in China
Source
American Shipper
Post Date
05/11/2020

The Food and Drug Administration 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 indepent 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.
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.


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