510(k) Report

Devices descending from K101468

1 later device reach 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…PRIMED Medical Products, Inc.20260—