QOZNot classified

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

Unknown

QOZ is the FDA product code for Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy. FDA's definition for this code reads: "A barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QOZ
Device name: Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy
FDA definition: A barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available 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.
Device class: Not classified
Review panel: Unknown
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QOZ

FDA records hold no clearances under product code QOZ.

Recent recalls

Product code QOZ

FDA records show no recalls under product code QOZ.

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 2026-09-06. View this product code on fda.gov (opens on fda.gov)