510(k) Report

Devices descending from K200522

2 later devices reach AERO CHROME* Breathable Performance Surgical Gowns through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.20260—
+1K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable…O&M Halyard, Inc.20210—