STERILE POWDERED LATEX SURGEON GLOVES
Device Facts
| Record ID | K010198 |
|---|---|
| Device Name | STERILE POWDERED LATEX SURGEON GLOVES |
| Applicant | Supermax Glove Manufacturing Sdn Bhd |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Feb 23, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
