K211036 is an FDA 510(k) clearance for the Plus Medical Chemotherapy 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 4, 2022, 392 days after receiving the submission on April 7, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2021 |
| Decision Date | May 04, 2022 |
| Days to Decision | 392 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 |