K212812 is an FDA 510(k) clearance for the Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Xianning Marveldas Protective Articles Co., Ltd. (Xianning, CN). The FDA issued a Cleared decision on November 16, 2022, 439 days after receiving the submission on September 3, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2021 |
| Decision Date | November 16, 2022 |
| Days to Decision | 439 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 |