510(k) Report

Devices descending from K160361

2 later devices reach PRIMAGARD Isolation Gown (AAMI PB70 Level 3) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3…Owens & Minor (O&M) Halyard, Inc.20240—
+1K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC20220—