← FDA Medical Device Classifications
Antimicrobial Drapes
PLY · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4370
Classification
- FDA Product Code
PLY- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4370
- Review panel
- HO
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 4
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown