K902633 is an FDA 510(k) clearance for the CUT RESISTANT GLOVE LINER. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 27, 1990, 43 days after receiving the submission on June 14, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K902633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1990 |
| Decision Date | July 27, 1990 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LYU — Accessory, Surgical Apparel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |