510(k) Report

Devices descending from K052824

2 later devices reach Kimberly-Clark Procedure Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…Cardinal Health200, LLC202011
+2K214108Medline Orbis Chemo Surgical GownMedline Industries, LP20220—