510(k) Report

Devices descending from K981393

13 later devices reach Microcool Surgical Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172954Medline Prevention CoolZone GownMedline Industries, Inc.20180—
+1K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc.20162—
+1K091357Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp.200982
+2K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3…Owens & Minor (O&M) Halyard, Inc.20240—
+2K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC20220—
+2K103406Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp.201072
+3K140539Aero Blue Performance Surgical GownKimberly-Clark Corporation20146—
+4K192362Aero Blue Performance Surgical GownsO&M Halyard, Inc.201901
+4K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc.20164—
+5K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc.20202—
+5K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.20170—
+6K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.20260—
+6K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable…O&M Halyard, Inc.20210—