- 44 reads
KN95 Masks for Civilian Use
Not all KN95 Masks are created equal. For civilian use some companies are importing KN95 Masks for civilian uses, and they are less expensive than KN95 Medical Mask products for uses in hospitals and in some cases for first responders or dentists that have more acute protection needs.
Good to know info is below and the FDA has made updates as well: https://www.ada.org/en/publications/ada-news/2020-archive/may/fda-removes-emergency-use-authorization-for-some-kn95-masks
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) Guidance for Industry and Food and Drug Administration Staff April 2020 This document supersedes “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” issued March 25, 2020.
Source: https://www.fda.gov/media/136449/download
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) Guidance for Industry and Food and Drug Administration Staff April 2020 This document supersedes “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” issued March 25, 2020. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Contains Nonbinding Recommendations Preface Public Comment This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or the Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)).
This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number FDA-2020-D-1138 and complete title of the guidance in the request. Additional Copies Additional copies are available from the FDA webpage titled “Coronavirus Disease 2019 (COVID-19),” available at https://www.fda.gov/emergency-preparedness-and-response/mcmissues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, and the FDA webpage titled “Search for FDA Guidance Documents,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 20018 and complete title of the guidance in the request.
