X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Device Facts
| Record ID | K010961 |
|---|---|
| Device Name | X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Applicant | Ansell Healthcare Products, Inc. |
| Product Code | LYY · General Hospital |
| Decision Date | May 31, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
