K041540 is an FDA 510(k) clearance for the COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 5, 2005, 331 days after receiving the submission on June 8, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K041540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2004 |
| Decision Date | May 05, 2005 |
| Days to Decision | 331 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |