K212357 is an FDA 510(k) clearance for the Surgical isolation gown. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Wuhan Zonsen Medical Products Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on January 20, 2022, 175 days after receiving the submission on July 29, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2021 |
| Decision Date | January 20, 2022 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |