STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
Device Facts
| Record ID | K132006 |
|---|---|
| Device Name | STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) |
| Applicant | Hartalega Sdn Bhd |
| Product Code | LZA · General Hospital |
| Decision Date | Nov 7, 2013 |
| 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.
