QKR — Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Class N
FDA product code QKR covers "Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QKR
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Unknown
- Implant
- No
Definition
Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download