510(k) Report

Devices descending from K210405

2 later devices reach ProTEC-USA EZDoff Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233526Medline Open-back Level 3 Protective GownMedline Industries, LP20241—
+2K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc.20260—