NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
Device Facts
| Record ID | K101820 |
|---|---|
| Device Name | NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES |
| Applicant | Yty Industry (Manjung) Sdn Bhd |
| Product Code | LZA · General Hospital |
| Decision Date | Mar 3, 2011 |
| 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.
