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2022-04-27

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.

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Careable biotechnology Co., Ltd

0086-0750-3082101
Building O, 3rd Hongxin Road, Jiangmen City, Guangdong, Jiangmen, Guangdong

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