Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
The Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EUA is a not-classified device intended to be worn by the general public or healthcare personnel to cover the nose and mouth; it may or may not meet fluid barrier or filtration efficiency levels, and is subject to FDA's COVID-19 enforcement policy or the Face Mask Umbrella EUA rather than standard premarket submission requirements. The product code is QKR, reviewed by the General Hospital panel. The device is GMP exempt and is not flagged as an implant or life-sustaining device.
Research product code QKR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QKR
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
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
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 270 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 270 registration numbers. Click on an entry to view related FDA registrations.