Frequently Asked Questions
Personal Protective Equipment EUAs
On the basis of this determination, the Secretary declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe
Official FDA Document PDF https://www.fda.gov/media/136664/download
Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes
https://multimedia.3m.com/mws/media/1791500O/comparison-ffp2-kn95-n95-filtering-facepiece-respirator-classes-tb.pdf
CDC -Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies
https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html
Information and FAQs on the Performance, Protection, and Sterilization of Face Mask Materials – Published April 2, 2020
https://utrf.tennessee.edu/information-faqs-performance-protection-sterilization-of-face-mask-materials/
Strategies for Optimizing the Supply of Isolation Gowns
https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/isolation-gowns.html
CDC NIOSH Approval information:
https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1sect2-m.html
3M has summarized the difference between KN95 & N95 masks in this document KN95 to NIOSH N95 3M Comparison .
Makrite Fitting Instructions PDF
https://www.vacovidsupplies.com/wp-content/uploads/2020/03/MakriteApproval5411.pdf