K032666 is an FDA 510(k) clearance for the MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Medline Industries, Inc. (Waukegan, US). The FDA issued a Cleared decision on March 16, 2005, 566 days after receiving the submission on August 28, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K032666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2003 |
| Decision Date | March 16, 2005 |
| Days to Decision | 566 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |