K203539 is an FDA 510(k) clearance for the Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE). This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Unicoglobal, Inc. (Seongnam, KR). The FDA issued a Cleared decision on December 10, 2021, 372 days after receiving the submission on December 3, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2020 |
| Decision Date | December 10, 2021 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |