510(k) Report

Devices descending from K182948

1 later device reach Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…Ansell Healthcare20230—