510(k) Report

Devices descending from K163146

41 later devices reach POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy DrugsHebei Titans Hongsen Medical Technology Co., Ltd.20180—
+1K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd201739—
+2K231740MemorialTM GlovesUs Glove Supply20230—
+2K212639Disposable Medical Nitrile Examination Gloves (Non sterile)Jiangsu Nanfang Medical Co., Ltd.20210—
+2K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy…Medline Industires, Inc.20208—
+2K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsHalyard Health20189—
+2K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd201817—
+3K222733Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)Inner Mongolia Boming Medical Supplies Co., Ltd.20220—
+3K222898SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC20221—
+3K222642Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)Inner Mongolia Cureguard Medical Technology Co., Ltd.20220—
+3K212834Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)Siyang Threeguard Medical Supplies Co., Ltd.20210—
+3K211608Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)Jiangsu Cureguard Glove Co., Ltd.20210—
+3K211714Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)Hengchang (Dongying) Medical Technology Co., Ltd.20211—
+3K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc.20212—
+3K190736Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With…Ever Growth (Vietnam) Co., Ltd.20192—
+3K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile…O&M Halyard, Inc.20193—
+3K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc.201911
+3K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd.201813—
+4K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000…Safesource Direct, LLC20250—
+4K234097Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use…Ever Growth (Vietnam) Corporation Limited20240—
+4K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.20241—
+4K221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…Jr Engineering & Medical Technologies (M) Sdn. Bhd.20220—
+4K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for…O&M Halyard, Inc.20220—
+4K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free…O&M Halyard, Inc.20220—
+4K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination…Kl-Kepong Rubber Products Sdn. Bhd.20220—
+4K213440Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with…Luliang Hongruida Health Protection Technology Co., Ltd.20225—
+4K213306Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy DrugsZibo Sinocare Plastic Products Co., Ltd.20220—
+4K211604Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy DrugsShanxi Hongjin Plastic Technology Co., Ltd.20210—
+4K212036Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy DrugsJiangsu Yanfang Medical Technology Co., Ltd.20210—
+4K210944Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)Harbour Health, LLC20215—
+5K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use…Kl-Kepong Rubber Products Sdn. Bhd.20250—
+5K240072Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With…Luliang Hongruida Health Protection Technology Co., Ltd.20240—
+5K223559Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Pharmaceuticals Corporation20233—
+5K213227Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)Uweport, LLC20221—
+5K213076AspenMed+Aspen Glove Sdn. Bhd.20210—
+5K212898Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With…Rimba Glove Snd Bhd20210—
+5K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…Jr Engineering & Medical Technologies (M) Sdn. Bhd.20210—
+6K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Nitrile, LLC20232—
+6K221350Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy…Rubberex Alliance Products Sdn Bhd20220—
+7K232654Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With…Nephron Nitrile, LLC20240—
+7K233970Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With…Nephron Nitrile, LLC20240—