K252301 is an FDA 510(k) clearance for the Henan Yadu Level 4 Surgical Gowns (Reinforced). 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 February 4, 2026, 195 days after receiving the submission on July 24, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K252301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2025 |
| Decision Date | February 04, 2026 |
| Days to Decision | 195 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 |