510(k) K223401

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) by Xiamen Probtain Medical Techology Co., Ltd. — Product Code FYA

K223401 is an FDA 510(k) premarket notification submitted by Xiamen Probtain Medical Techology Co., Ltd. for the device "Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)". The FDA issued a decision of Substantially Equivalent on March 7, 2023. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Xiamen Probtain Medical Techology Co., Ltd. has at least 3 other 510(k) clearances on record.