QKU — Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) Class N
FDA product code QKU covers "Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QKU
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Unknown
- Implant
- No
Definition
For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see: https://www.fda.gov/media/136664/download). *This excludes NIOSH-approved respirators that are under EUA *This includes authorized KN95s from China under EUA *This excludes KN95s imported under enforcement discretion that dont have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA