May 7, 2020 / 6:40 PM / 25 days ago

FDA withdraws approval of some mask makers in China to sell in U.S

(Reuters) - The U.S. Food and Drug Administration on Thursday announced that it has canceled the approval for some manufacturers in China to sell N95 respirators in the United States, as they failed to offer adequate protection against the new coronavirus.

A number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95% upon testing, the agency said. (bit.ly/35JPxQW)

The Centers for Disease Control and Prevention (CDC) lists N95 masks, which are designed to filter at least 95% of airborne particles, as critical protective supplies that must be reserved for the use of health care workers amid a steep surge in demand due to the COVID-19 pandemic.

The FDA’s move on Thursday follows its decision last month to ask China to revise new export quality control rules for protective equipment needed, so they are not an obstacle to timely supplies.

The agency said it had previously authorized the use of those respirators manufactured in China that have been tested by a recognized independent laboratory, even if they hadn’t been tested by U.S. authorities.

However, as a number of these respirators failed to meet the minimum performance standards, the FDA said it was withdrawing the approval of all respirators authorized under the previous criterion.

Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber

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