FDA product code QZT: Gowns And Other Apparel
QZT is the FDA product code for gowns and other apparel. It is a Not classified device, reviewed by the General Hospital panel. Devices under QZT reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Gowns and other apparel are authorized under the EUA for use by HCPs in healthcare settings in accordance with CDC recommendations to protect both HCPs and patients from the transfer of SARS-CoV-2 in low or minimal risk level situations to prevent the spread of COVID-19.
Classification
| Field | Value |
|---|---|
| Device name | Gowns And Other Apparel |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QZT devices
openFDA lists no recalls for product code QZT.
Frequently asked questions
What is FDA product code QZT?
QZT is the FDA product code for gowns and other apparel. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QZT?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QZT
- Run a recall and safety report across every QZT manufacturer
- Watch product code QZT 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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