OPC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Powder-Free Polychloroprene Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) (K211758) | Hartalega NGC Sdn. Bhd. | 2021-08-03 | + Add |
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Every clearance here is in the API, with alerts when new ones post.