Powder-Free Polychloroprene Patient Examination Glove
The Powder-Free Polychloroprene Patient Examination Glove (product code OPC) is a Class 1 General Hospital device regulated under 21 CFR 880.6250, cleared via 510(k). It is a disposable glove made of polychloroprene rubber, worn on the hand during medical examinations or procedures to provide a barrier against potentially infectious materials and other contaminants; notably, while described as powder-free in the device name, the definition references bearing powder to facilitate donning, which may reflect a database discrepancy. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OPC
- Device Class
- FDA class 1
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) | Aug 03, 2021 | Substantially Equivalent | Hartalega NGC Sdn. Bhd. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.