K932404 is an FDA 510(k) clearance for the NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE. This device is classified as a Patient Examination Glove (Class I - General Controls, product code FMC).
Submitted by Safeskin Corp. (Boca Raton, US). The FDA issued a Cleared decision on May 18, 1994, 370 days after receiving the submission on May 13, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K932404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1993 |
| Decision Date | May 18, 1994 |
| Days to Decision | 370 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMC — Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |