K993170 is an FDA 510(k) clearance for the MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE 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 2, 2000, 162 days after receiving the submission on September 22, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K993170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 1999 |
| Decision Date | March 02, 2000 |
| Days to Decision | 162 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 |