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HomeNewsTwo Models FFP2 Mask Authorized by FDA on EUA List

Two Models FFP2 Mask Authorized by FDA on EUA List

2020-07-24

Today we received a letter from FDA, the letter is in response to Careable biotechnology`s request that the Food and Drug Administration (FDA) add your respirator models CARE002 and CARE003 as authorized respirators to the Emergency Use Authorization (EUA) for non-NIOSH-approved filtering facepiece respirators manufactured in China, which was revised and reissued under Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) on June 6, 2020. We have reviewed your request to be added to Appendix A of this EUA and determined that models included meet the eligibility criteria in the June 6, 2020 EUA for non-NIOSH approved respirators made in China. As such, your respirator(s) is hereby added to Appendix A as an authorized respirator.

FDA Screenshot


You can check on the following link: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixa


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