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Some Respirators Removed from Appendix A of the EUA

Some respirators failed to demonstrate a filtration efficiency of 95% when tested.

coronavirus

On May 7, the Food and Drug Administration (FDA) sent an open letter to healthcare providers indicating that due to substandard performance, they have revised and reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China.

A number of respirators “failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.” This resulted in the removal of several companies from Appendix A.

The respirators that did not meet their labeled performance standard are no longer eligible and are no longer authorized to be marketed or distributed as respirators in the United States.

Please reach out to your local DSV Customs and Compliance representative with any questions.