WASHINGTON – Federal health officials have revoked U.S. authorization for masks made by more than 60 Chinese manufacturers after they failed to meet standards needed to protect health care workers.
The Food and Drug Administration had allowed the imports based on testing data from the companies. Normally, the masks are tested and certified by a division of the Centers for Disease Control and Prevention before they can be sold in the U.S.
The tight-fitting masks are essential for protecting health care workers treating patients with COVID-19. Faced with critical shortages at U.S. hospitals, the U.S. has accepted donations of masks, gloves and other protective equipment from China and other countries.
The Chinese masks are a version of N95 masks, which have filtration material to keep out at least 95% of particles. The FDA and CDC reported Thursday that new U.S. testing showed dozens of the Chinese masks failed to meet that 95% level. Some of the masks filtered as little as 20% of particles, according to the testing information from the CDC.
Only 14 Chinese masks met U.S. standards, according to an updated list distributed by the FDA. About 80 masks were previously authorized by the FDA beginning in early April.
The FDA said in a letter to health care facilities that the masks could still be used as face coverings to help reduce the spread of airborne droplets when people speak, cough or sneeze.
This week's FDA decision does not affect imported masks authorized by other foreign regulators, such as the European Union.
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