510(k) Report

Devices descending from K013302

22 later devices reach Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC20151—
+1K113707Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services201228
+1K111139Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for UAnsell Healthcare Products, Inc.201153
+1K103714Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with ChemotheraAnsell Healthcare Products, LLC20111—
+1K110272Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugCardinal Health, Inc.201161
+1K102500Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc.20107—
+2K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…Careplus (M) Sdn Bhd20210—
+2K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…Molnlycke Health Care Us, LLC20200—
+2K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC20193—
+2K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use…Cardinal Health, Inc.20170—
+2K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…Cardinal Health, Inc.20161—
+2K152428SensiCare PI Surgical GlovesMedline Industries, Inc.20162—
+2K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera…Medline Industries, Inc.20150—
+2K122557Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd.20133—
+3K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…Ansell Healthcare Products, LLC20230—
+3K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Hartalega NGC Sdn. Bhd.20221—
+3K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsBetter Care Plastic Technology Co., Ltd.20170—
+3K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsWrp Asia Pacific Sdn. Bhd.20170—
+3K140989Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine)Hebei Hongsen Plastics Technology Co, Ltd.20142—
+4K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.20230—
+4K170515Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited20171—
+5K222350Sterile Nitrile Surgical Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.20230—