510(k) Report

Devices descending from K880382

3 later devices reach Kimberly-Clark Impervious Open Back Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052824Kimberly-Clark Procedure GownKimberly-Clark Corp.20062—
+2K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…Cardinal Health200, LLC202011
+3K214108Medline Orbis Chemo Surgical GownMedline Industries, LP20220—