510(k) Report

Devices descending from K140539

6 later devices reach Aero Blue Performance Surgical Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192362Aero Blue Performance Surgical GownsO&M Halyard, Inc.201901
+1K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc.20164—
+2K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc.20202—
+2K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.20170—
+3K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.20260—
+3K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable…O&M Halyard, Inc.20210—