FDA Slashes Number of Approved Chinese Makers of N95 Masks

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FDA Slashes Number of Approved Chinese Makers of N95 Masks

modernClinician Editorial Team Posted May 8th

Cut comes after officials found that many imported N95 masks did not meet U.S. standards

FRIDAY, May 8, 2020 (HealthDay News) — The number of mask makers in China approved to make N95-type masks for U.S. health care workers was slashed from 80 to 14 by the U.S. Food and Drug Administration on Thursday.

The cut in approved mask makers comes after U.S. officials found that many imported N95 masks did not meet U.S. standards, MarketWatch reported.

For example, tests of 67 different kinds of imported masks showed that 60 percent failed to meet U.S. standards to filter out 95 percent of tiny particles. Masks from one Chinese company filtered out only 24 to 35 percent of particles.

The FDA’s action reversed a decision it made on April 3 that approved all 80 Chinese N95 mask makers, MarketWatch reported.

MarketWatch Article