510(k) Report

Devices descending from K162442

1 later device reach ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230707Skypro, Surgical Gown 6021Skypro Medical Supplies Company20230—