510(k) Report

Devices descending from K925077

6 later devices reach Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsBam Corporation Limited20175—
+2K203821Donagamex Blue Performance Protective GownDong Nai Garment Corporation (Donagamex)20210—
+2K210405ProTEC-USA EZDoff GownCadillac Products, Inc.20212—
+2K211538Protect X Level 3 Isolation GownAzac Group20210—
+3K233526Medline Open-back Level 3 Protective GownMedline Industries, LP20241—
+4K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc.20260—