510(k) Report

Devices descending from K071746

7 later devices reach Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171375Gammex PI Breach Detect Powder Free Surgical GloveAnsell Healthcare Products, LLC20180—
+1K151694Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC20165—
+2K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsAnsell Healthcare Products, LLC20191—
+2K171047Sterile Polyisoprene Powder Free Surgical GlovesBetter Care Plastic Technology Co., Ltd.20172—
+3K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…Ansell Healthcare20230—
+3K230304Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd.20230—
+3K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc.20210—