K052833 is an FDA 510(k) clearance for the GORE-TEX NON-STERILE SURGICAL GOWNS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 15, 2006, 132 days after receiving the submission on October 6, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K052833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2005 |
| Decision Date | February 15, 2006 |
| Days to Decision | 132 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |