FDA product code QOZ: Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy
QOZ is the FDA product code for barrier face covering within the scope of the face mask and barrier face covering enforcement policy. It is a Not classified device, reviewed by the General Hospital panel. Devices under QOZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A barrier face covering is a product worn on the face, specifically covering at least the wearers 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.
Classification
| Field | Value |
|---|---|
| Device name | Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for QOZ devices
openFDA lists no recalls for product code QOZ.
Frequently asked questions
What is FDA product code QOZ?
QOZ is the FDA product code for barrier face covering within the scope of the face mask and barrier face covering enforcement policy. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QOZ?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QOZ
- Run a recall and safety report across every QOZ manufacturer
- Watch product code QOZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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