FDA product code PLY: Antimicrobial Drapes
PLY is the FDA product code for antimicrobial drapes. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. Devices under PLY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure.
Classification
| Field | Value |
|---|---|
| Device name | Antimicrobial Drapes |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for PLY devices
openFDA lists no recalls for product code PLY.
Frequently asked questions
What is FDA product code PLY?
PLY is the FDA product code for antimicrobial drapes. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is PLY?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PLY
- Run a recall and safety report across every PLY manufacturer
- Watch product code PLY 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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