OPCClass I
Powder-Free Polychloroprene Patient Examination Glove
21 CFR 880.6250 / General Hospital
OPC is the FDA product code for Powder-Free Polychloroprene Patient Examination Glove, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OPC
- Device name
- Powder-Free Polychloroprene Patient Examination Glove
- FDA 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.
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OPC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
Applicants with the most clearances
Product code OPC| Applicant | Clearances |
|---|---|
| Hartalega NGC Sdn Bhd | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.