OIG · Powder-Free Guayle Rubber Examination Glove
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | OIG |
|---|---|
| Device Name | Powder-Free Guayle Rubber 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 |
|---|---|---|---|---|
| K063810 | YULEX LATEX POWDER-FREE EXAM GLOVES | Yulex Corporation | Apr 18, 2008 | SESE |
Top Applicants
- Yulex Corporation — 1 clearance
