510(k) Report

Devices descending from K151694

5 later devices reach Gammex PI Hybrid Surgical Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsAnsell Healthcare Products, LLC20191—
+1K171047Sterile Polyisoprene Powder Free Surgical GlovesBetter Care Plastic Technology Co., Ltd.20172—
+2K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…Ansell Healthcare20230—
+2K230304Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd.20230—
+2K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc.20210—