510(k) K250564

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) by Yadu Medical (Henan) Co., Ltd. — Product Code FYA

K250564 is an FDA 510(k) premarket notification submitted by Yadu Medical (Henan) Co., Ltd. for the device "Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)". The FDA issued a decision of Substantially Equivalent on December 3, 2025. 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.