510(k) Report

Devices descending from K091357

8 later devices reach Microcool Surgical Gown, Breathable High Performance KC400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103406Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp.201072
+2K140539Aero Blue Performance Surgical GownKimberly-Clark Corporation20146—
+3K192362Aero Blue Performance Surgical GownsO&M Halyard, Inc.201901
+3K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc.20164—
+4K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc.20202—
+4K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.20170—
+5K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.20260—
+5K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable…O&M Halyard, Inc.20210—