510(k) Report

Devices descending from K081089

86 later devices reach Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy…O&M Halyard, Inc.20191—
+1K162186Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with…Brightway Holdings Sdn. Bhd.20170—
+1K141982Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Wrp Asia Pacific Sdn. Bhd.201567—
+1K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Kimberly-Clark Corp.20108—
+1K101596Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…Kimberly-Clark201011—
+2K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile*…O&M Halyard, Inc.20250—
+2K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…0 & M Halyard, Inc.20204—
+2K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy…O&M Halyard, Inc.20200—
+2K192241Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam…O&M Haylard, Inc.20200—
+2K161929Palm-Pro Chemo-Guard Nitrile Powder Free Examination GloveDipped Products (Thailand) Limited20170—
+2K162405Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling…Comfort Rubber Gloves Industries Sdn. Bhd.20172—
+2K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsHebei Hongsen Plastics Technology Co, Ltd.201741—
+2K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy…Yty Industry (Manjung) Sdn Bhd20160—
+2K161422Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Wrp Asia Pacific Sdn. Bhd.20169—
+2K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy…Eco Medi Glove Sdn. Bhd.20168—
+2K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd20160—
+2K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp.20125—
+3K232538Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested for Use with…Wrp Asia Pacific Sdn. Bhd.20230—
+3K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc.20221—
+3K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free…O&M Halyard, Inc.20221—
+3K214110Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With…Mah Sing Healthcare Sdn. Bhd.20221—
+3K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy DrugsHebei Titans Hongsen Medical Technology Co., Ltd.20180—
+3K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd20183—
+3K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsComfort Rubber Gloves Industries Sdn. Bhd.20181—
+3K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with…Koon Seng Sdn Bhd20185—
+3K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd201739—
+3K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy…Eco Medi Glove Sdn. Bhd.20173—
+3K162294Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use…Brightway Holdings Sdn. Bhd.20170—
+3K162381HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy DrugsHealthy Glove Co., Ltd.20170—
+3K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health20162—
+4K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…O&M Halyard, Inc.20260—
+4K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc.20250—
+4K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.20240—
+4K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd.20230—
+4K231740MemorialTM GlovesUs Glove Supply20230—
+4K230002Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with…Mah Sing Healthcare Sdn. Bhd.20230—
+4K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and…Pt. Maja Agung Latexindo20221—
+4K212639Disposable Medical Nitrile Examination Gloves (Non sterile)Jiangsu Nanfang Medical Co., Ltd.20210—
+4K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy…Medline Industires, Inc.20208—
+4K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd20192—
+4K190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With…Ever Global (Vietnam) Enterprise Corporation20194—
+4K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling…Comfort Rubber Gloves Industries Sdn. Bhd.20190—
+4K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsOwens & Minor Halyard, Inc.20180—
+4K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsHalyard Health20189—
+4K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd201817—
+5K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl…Basic Medical Technology, Inc.20250—
+5K222733Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)Inner Mongolia Boming Medical Supplies Co., Ltd.20220—
+5K222898SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC20221—
+5K222642Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)Inner Mongolia Cureguard Medical Technology Co., Ltd.20220—
+5K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd.20221—
+5K212834Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)Siyang Threeguard Medical Supplies Co., Ltd.20210—
+5K211608Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)Jiangsu Cureguard Glove Co., Ltd.20210—
+5K211714Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)Hengchang (Dongying) Medical Technology Co., Ltd.20211—
+5K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc.20212—
+5K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corp20203—
+5K190736Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With…Ever Growth (Vietnam) Co., Ltd.20192—
+5K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile…O&M Halyard, Inc.20193—
+5K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc.201911
+5K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd.201813—
+6K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000…Safesource Direct, LLC20250—
+6K244034Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corporation20251—
+6K234097Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use…Ever Growth (Vietnam) Corporation Limited20240—
+6K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.20241—
+6K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl…Zhonghong Pulin Medical Products Co., Ltd.20230—
+6K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd.20230—
+6K221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…Jr Engineering & Medical Technologies (M) Sdn. Bhd.20220—
+6K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for…O&M Halyard, Inc.20220—
+6K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free…O&M Halyard, Inc.20220—
+6K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination…Kl-Kepong Rubber Products Sdn. Bhd.20220—
+6K213440Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with…Luliang Hongruida Health Protection Technology Co., Ltd.20225—
+6K213306Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy DrugsZibo Sinocare Plastic Products Co., Ltd.20220—
+6K211604Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy DrugsShanxi Hongjin Plastic Technology Co., Ltd.20210—
+6K212036Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy DrugsJiangsu Yanfang Medical Technology Co., Ltd.20210—
+6K210944Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)Harbour Health, LLC20215—
+7K252244Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corporation20250—
+7K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use…Kl-Kepong Rubber Products Sdn. Bhd.20250—
+7K240072Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With…Luliang Hongruida Health Protection Technology Co., Ltd.20240—
+7K223559Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Pharmaceuticals Corporation20233—
+7K213227Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)Uweport, LLC20221—
+7K213076AspenMed+Aspen Glove Sdn. Bhd.20210—
+7K212898Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With…Rimba Glove Snd Bhd20210—
+7K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…Jr Engineering & Medical Technologies (M) Sdn. Bhd.20210—
+8K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Nitrile, LLC20232—
+8K221350Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy…Rubberex Alliance Products Sdn Bhd20220—
+9K232654Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With…Nephron Nitrile, LLC20240—
+9K233970Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With…Nephron Nitrile, LLC20240—