K250564 is an FDA 510(k) clearance for the Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL). This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Yadu Medical (Henan) Co., Ltd. (He Nan, CN). The FDA issued a Cleared decision on December 3, 2025, 280 days after receiving the submission on February 26, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K250564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2025 |
| Decision Date | December 03, 2025 |
| Days to Decision | 280 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 |