510(k) K252301
K252301 is an FDA 510(k) premarket notification submitted by Yadu Medical (Henan) Co., Ltd. for the device "Henan Yadu Level 4 Surgical Gowns (Reinforced)". The FDA issued a decision of Substantially Equivalent on February 4, 2026. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Yadu Medical (Henan) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2026
- Date Received
- July 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type