中康防护科技有限公司产品正式通过FDA EUA授权

作者:中康防护用品科技来源:中康防护用品科技(广州)有限公司



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ZHONGKANG PROTECTIVE EQUIPMENT TECHNOLOGY CO., LTD

3/F, BUILDING A, NO.88,

WEST DAGANG STREET

BAIYUNHU ROAD

GUANGZHOU CN - CHINA


EUA200548/A001


Re: FFRs Made in China


Dear Maggie Chen:


This letter is in response to your request that the Food and Drug Administration (FDA) add your respirator model ZK601 as an authorized respirator to the Emergency Use Authorization (EUA) for non-NIOSH-approved filtering facepiece respirators manufactured in China1, 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 model included meets 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.


Having concluded that the eligibility criteria are met, I am adding your respirators to Appendix A, as described in the Scope of Authorization (Section II). As such, these respirator models are authorized for use by healthcare personnel in healthcare settings in accordance with CDC recommendations and subject to the Conditions of Authorization (Section IV) of the attached letter. We remind you that, among other things, you are required to meet the following labeling requirements:


Manufacturers

          A. Manufacturers of authorized respirators are required to publish the intended use and other instructions (such as fit testing, etc.) about all authorized

modelsthat are imported and authorized under this EUA on their website in English. Additionally, manufacturers must notify FDA by emailing FDA at

CDRH-NonDiagnosticEUA- Templates@fda.hhs.gov of the website address (URL) that meets thiscondition.Thesubjectlineofthisemailshouldread“URLfor

FFR Made in China.”FDAwillmake this information available to the public on its EUA website at   https://www.fda.gov/medical- devices/coronavirus-disease-

2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas. Manufacturers must notify FDA of any changes to this page.


        B.In addition to the above electronic labeling condition, manufacturers of authorized respirators are additionally required to include a letter, in English, that can bedistributed to each end user facility (e.g., each hospital, etc.) that receives the authorized respirator model. This letter must include theauthorized respirator’smanufacturer, model, intended use, manufacturer’s webpage (if applicable), etc.




1 The EUA Letter of

Authorization is available at, https://www.fda.gov/media/136664/download.






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Additionally, please be advised that if your firm does not have the appropriate fluid resistance testing, the respirator should not be labeled as “surgical.”


Import information can be found on the Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 page. If you need to resolve entry issues for shipments, please contact 301-796-0356 or COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.



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