K931094 is an FDA 510(k) clearance for the PROCEL(TM) DERMALINER GLOVE. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 14, 1994, 348 days after receiving the submission on March 3, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K931094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1993 |
| Decision Date | February 14, 1994 |
| Days to Decision | 348 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LYU — Accessory, Surgical Apparel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |