FDA bans faulty masks, 3 weeks after failed tests

Following quality tests conducted by CDC weeks ago, FDA on May 7 prohibited the sale of defective N95-style face masks from more than 65 of 80 manufacturers in China authorized by FDA. An FDA spokeswoman said the agency would collaborate with CDC to increase the supply of masks and ensure their quality.

Following quality tests conducted by CDC weeks ago, FDA on May 7 prohibited the sale of defective N95-style face masks from more than 65 of 80 manufacturers in China authorized by FDA. An FDA spokeswoman said the agency would collaborate with CDC to increase the supply of masks and ensure their quality. Prior to its decision, FDA allowed the sale of several types of masks for 3 weeks, allowing millions of the masks to be purchased by or donated to American hospitals and distributed to others working on the front lines against the COVID-19 outbreak. Hospitals and health care workers were reluctant to use China's KN95 masks, but because of the shortage of official N95 masks, many were compelled to use them. The KN95 masks were required to be vetted by an accredited test lab, which can be outside the United States, showing they meet CDC's standards, which call for filtering 95% of particles that are 0.3 microns or larger, including the new coronavirus. FDA said on Thursday that too many of the masks failed to filter out a sufficient percentage of particles.