PLY — Antimicrobial Drapes Class II
FDA product code PLY covers "Antimicrobial Drapes", a Class II medical device regulated under 21 CFR 878.4370. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- PLY
- Device Class
- Class II
- Regulation Number
- 878.4370
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure.