510(k) Report

Devices descending from K011721

14 later devices reach Esteem Sterile Polyisoprene Surgical Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093300Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc.20098—
+1K092304Esteem Ortho Polyisoprene Powder-Free Surgical GlovesCardinal Health, Inc.20091—
+1K050181Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical GlovesMedigloves, Ltd.20050—
+1K042574Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin…Cardinalhealth200418
+2K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…Cardinal Health, Inc.20160—
+2K123126Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) and # 6512(6532)Shanghai Motex Healthcare Co., Ltd.20140—
+2K111868Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient CoatingCardinal Health-Medical Products and Services20110—
+2K110272Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugCardinal Health, Inc.201161
+3K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use…Cardinal Health, Inc.20170—
+3K152428SensiCare PI Surgical GlovesMedline Industries, Inc.20162—
+3K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC20151—
+4K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…Molnlycke Health Care Us, LLC20200—
+4K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsBetter Care Plastic Technology Co., Ltd.20170—
+4K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsWrp Asia Pacific Sdn. Bhd.20170—