510(k) Report

Devices descending from K952115

2 later devices reach Barrier Gown, Kool-Gard Backless Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health200, LLC20191—
+2K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation20220—