EUA confirmation letter of ZHONGKANG
August 19, 2020
ZHONGKANG PROTECTIVE EQUIPMENT TECHNOLOGY CO., LTD.
3/F, BUILDING A, NO. 88 WEST DAGANG STREET,
BAIYUNHU ROAD, BAIYUN DISTRICT,
GUANGZHOU, GUANGDONG, CHINA 510000
Re: FFRs Made in China
This letter is in response to your request that the Food and Drug Administration (FDA) add your respirator model ZK626 Brand Name: Careplus 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 (theAct) (21U.S.C.§360bbb3) 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 criteriain the June6,2020 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:
A. Manufacturers of authorized respirators are required to publish the intended use and other instructions (such as fit testing, etc.) about all authorized models that 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 this condition. The subject line of this email should read “URL for FFR Made in China.” FDA will make 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 be distributed to each end user facility
(e.g., each hospital, etc.) that receives the authorized respirator model. This letter must include the authorized respirator’s manufacturer, model, intended use, manufacturer’s webpage (if applicable), etc.
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903