STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
Device Facts
| Record ID | K002933 |
|---|---|
| Device Name | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES |
| Applicant | Maxxim Medical |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Oct 19, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.
