# Powder-Free Polychloroprene Patient Examination Glove
> **Product code: OPC** · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6250
## Classification
- **FDA Product Code:** OPC
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 880.6250
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OPC)
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