Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
Device Facts
| Record ID | K260860 |
|---|---|
| Device Name | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) |
| Applicant | Basic Medical Technology, Inc. |
| Product Code | LYZ · General Hospital |
| Decision Date | Apr 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
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.
