K160471 is an FDA 510(k) clearance for the Medline Non-Surgical Isolation Gown-. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 31, 2017, 347 days after receiving the submission on February 19, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K160471 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2016 |
| Decision Date | January 31, 2017 |
| Days to Decision | 347 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYC — Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |