FDA product code QMF: Mask, Surgical, Eua Authorized
QMF is the FDA product code for mask, surgical, eua authorized. It is a Not classified device, reviewed by the General Hospital panel. Devices under QMF reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Surgical masks for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the declared public health emergency. Surgical masks that have been designed, evaluated, and validated consistent with the conditions set forth in FDA's EUA Authorization letter for these devices and that are not excluded from the scope and are not authorized under the EUA.
Classification
| Field | Value |
|---|---|
| Device name | Mask, Surgical, Eua Authorized |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QMF devices
openFDA lists no recalls for product code QMF.
Frequently asked questions
What is FDA product code QMF?
QMF is the FDA product code for mask, surgical, eua authorized. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QMF?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QMF
- Run a recall and safety report across every QMF manufacturer
- Watch product code QMF 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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