510(k) K231510

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) by Xiantao Zhibo Non-Woven Products Co., Ltd. — Product Code FYA

K231510 is an FDA 510(k) premarket notification submitted by Xiantao Zhibo Non-Woven Products Co., Ltd. for the device "Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)". The FDA issued a decision of Substantially Equivalent on Aug 22, 2023. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Xiantao Zhibo Non-Woven Products Co., Ltd. has 1 other 510(k) clearance on record.