510(k) K260725

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) by Hindernis DE Mexico, S.A.P.I. DE C.V. — Product Code FYA

K260725 is an FDA 510(k) premarket notification submitted by Hindernis DE Mexico, S.A.P.I. DE C.V. for the device "BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)". The FDA issued a decision of Substantially Equivalent on May 12, 2026. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.