QKRNot classified

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Unknown

QKR is the FDA product code for Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: QKR
Device name: Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
FDA 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
Device class: Not classified
Review panel: Unknown
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 268 companies shown, in name order

Recent clearances

Product code QKR

FDA records hold no clearances under product code QKR.

Recent recalls

Product code QKR

Z-0107-2021Class IIDisposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.Beyond White Spa Llc D.b.a. Ezywipe of Amercia / initiated 2020-07-21 / 18,500,000 Masks

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)