OPC · Powder-Free Polychloroprene Patient Examination Glove
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | OPC |
|---|---|
| Device Name | Powder-Free Polychloroprene Patient Examination Glove |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) | Hartalega NGC Sdn. Bhd. | Aug 3, 2021 | SESE |
Top Applicants
- Hartalega NGC Sdn. Bhd. — 1 clearance
