K003755 is an FDA 510(k) clearance for the MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 16, 2001, 73 days after receiving the submission on December 5, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K003755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2000 |
| Decision Date | February 16, 2001 |
| Days to Decision | 73 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 |