510(k) K261028
K261028 is an FDA 510(k) premarket notification submitted by Yadu Medical (Henan) Co., Ltd. for the device "Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)". The FDA issued a decision of Substantially Equivalent on August 7, 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 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2026
- Date Received
- March 30, 2026
- 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