K213177 is an FDA 510(k) clearance for the Plus Medical Cover Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 11, 2022, 225 days after receiving the submission on September 28, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K213177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2021 |
| Decision Date | May 11, 2022 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |