OPC — Powder-Free Polychloroprene Patient Examination Glove Class I
FDA product code OPC covers "Powder-Free Polychloroprene Patient Examination Glove", a Class I medical device regulated under 21 CFR 880.6250. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OPC
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K211758 | hartalega ngc sdn. bhd | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy D | August 3, 2021 |