The Food and Drug Administration (FDA) has revoked approval for more than 60 N95-type mask manufacturers in China to export to the United States, after testing found that many of their products did not meet quality standards.
The agency on May 7 cut the number of authorized manufacturers in China to 14 from around 80. Previously, on April 3, it had authorized the import of China-made masks that hadn’t been tested to counter shortages in personal protective equipment. One condition of that policy, however, was that the masks be tested by independent labs. Millions of masks had been imported since then.
Testing by the National Institute for Occupational Safety and Health (NIOSH) under the Centers for Disease Control and Prevention found that many of the masks did not meet the filtration standard—that is, they should filter out 95 percent of particles that are 0.3 microns or larger, according to the FDA.
In April, Missouri recalled thousands of KN95 masks from China that had been distributed to first responders, after testing found that that they did not meet standards.