# Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
> **Product code: QPC** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4040
## Classification
- **FDA Product Code:** QPC
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4040
- **Review panel:** HO
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 18
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QPC)
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