ClearanceBrief
510(k) K260725 · FYA Gown, Surgical

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

ApplicantHindernis DE Mexico, S.A.P.I. DE C.V., Naucalpan De Juarez, MX
DecisionSubstantially Equivalent, May 12, 2026
ReceivedMar 5, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260725

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.