K043017 is an FDA 510(k) clearance for the PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Medline Industries, Inc. (Waukegan, US). The FDA issued a Cleared decision on March 8, 2005, 126 days after receiving the submission on November 2, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K043017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2004 |
| Decision Date | March 08, 2005 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |