K212422 is an FDA 510(k) clearance for the Disposable Surgical Isolation Gown. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Crown Name Disposable Hygiene Products Fty., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on April 29, 2022, 268 days after receiving the submission on August 4, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2021 |
| Decision Date | April 29, 2022 |
| Days to Decision | 268 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 |