510(k) Report

Devices descending from K153255

4 later devices reach Aero Chrome* Breathable Performance Surgical Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc.20202—
+1K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.20170—
+2K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.20260—
+2K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable…O&M Halyard, Inc.20210—