PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF
Device Facts
| Record ID | K914628 |
|---|---|
| Device Name | PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF |
| Applicant | Medical Resources, Ltd. |
| Product Code | LYY · General Hospital |
| Decision Date | Nov 7, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
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.
