510(k) K253003

Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) by Hubei Xinxin Non-Woven Co., Ltd. — Product Code FYA

K253003 is an FDA 510(k) premarket notification submitted by Hubei Xinxin Non-Woven Co., Ltd. for the device "Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)". The FDA issued a decision of Substantially Equivalent on April 20, 2026. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Hubei Xinxin Non-Woven Co., Ltd. has at least 3 other 510(k) clearances on record.