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Polymer Patient Examination Glove

Regulation 880.6250

17510(k)s in 12 months (1,182 all time)
3recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in LZA

Company510(k)sRecalls
Shen Wei (Usa), Inc.340
Hartalega Sdn Bhd330
Hartalega NGC Sdn. Bhd.240
Smart Glove Corp. Sdn Bhd190
Siam Sempermed Corp., Ltd.170
Yty Industry (Manjung) Sdn Bhd170
Gx Corporation Sdn Bhd150
Wrp Asia Pacific Sdn. Bhd.150
Eco Medi Glove Sdn. Bhd.140
O&M Halyard, Inc.140
Decided510(k)Device and applicantCode
Dec 10, 2021K212922Nitrile Examination Gloves
Hsk Medical Apparatus Foshan China Co., Ltd., CN
LZA
Dec 10, 2021K212850ComfortPro Blue Nitrile Examination Gloves Powder Free
Thai Rubber Industry Company Limited, TH
LZA
Dec 10, 2021K212349Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
Medi Legion Sdn.Bhd, MY
LZA
Dec 9, 2021K213371Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
Anhui Xinyisheng Medical Technology Co.,Ltd, CN
LZA
Dec 4, 2021K212535Nitrile Powder Free Blue Examination Gloves, Non-Sterile
Mah Sing Healthcare Sdn. Bhd., MY
LZA
Dec 2, 2021K212802powder free nitrile examination glove - white, non-sterile
Hong Seng Gloves Sdn Bhd, MY
LZA
Dec 2, 2021K212578Nitrile disposable examination gloves
Xingyu Medical Tech Co., Ltd., CN
LZA
Dec 1, 2021K212804Powder free nitrile examination glove- blue, non-sterile
Hong Seng Gloves Sdn Bhd, MY
LZA
Dec 1, 2021K212789Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
5r Med Instruments (Chengdu) Co., Ltd., CN
LZA
Nov 26, 2021K212722Nitrile Examination Gloves
Wuhan Huirui Technology Co., Ltd., CN
LZA
Nov 22, 2021K210990Non-sterile Powder Free Nitrile Examination Gloves
Rubberex Alliance Sdn Bhd, MY
LZA
Nov 19, 2021K212661Disposable Nitrile Examination Glove
Inner Mongolia Cureguard Medical Technology Co., Ltd., CN
LZA
Nov 19, 2021K211063HALYARD Flexaprene Green Powder-Free Exam Glove
O&M Halyard, Inc.
LZA
Nov 18, 2021K212600Disposable Medical Nitrile Examination Gloves (Non-sterile)
Suqian Linglian Medical Technology Co., Ltd., CN
LZA
Nov 16, 2021K212029Disposable Medical Nitrile Examination Gloves (non-sterile)
Taizhou Kangjian Medical Equipments Co., Ltd., CN
LZA
Nov 11, 2021K212532Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
Crdlight Optoelectronic Technology Co., Ltd., CN
LZA
Nov 11, 2021K212497Nitrile Examination Glove (Powder free, Blue)
Jiangsu Jinlian Medical Technology Co., Ltd., CN
LZA
Nov 10, 2021K210779Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Shangwei Medical Products Co., Ltd., CN
LZA
Nov 7, 2021K212506Medical Examination Gloves (Tested for Use with Chemotherapy)
Guangdong Gymda Medical Technology Co.,Ltd, CN
LZA
Nov 5, 2021K212551Nitrile Examination Gloves
Anhui Fine Glove Medical Technology Co., Ltd., CN
LZA
Nov 5, 2021K212485Disposable Nitrile Examination gloves
Fujian Yuanxin Safety Protection Technology Co., Ltd., CN
LZA
Nov 4, 2021K212467Disposable Nitrile Examination Glove
Inner Mongolia Boming Medical Supplies Co., Ltd., CN
LZA
Nov 2, 2021K210777Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Jieshi Medical Products Co., Ltd., CN
LZA
Nov 1, 2021K211586Nitrile Examination Gloves (Blue, Violet)
Lyncmed Medical Technology (Beijing) Co., Ltd., CN
LZA
Oct 31, 2021K210588Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd, MY
LZA
Oct 29, 2021K212308SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
Srirungruang Global Co., Ltd., TH
LZA
Oct 28, 2021K212290Examination gloves -Type C (Nitrile gloves)
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., CN
LZA
Oct 28, 2021K211581Disposable Nitrile Examination Gloves (Powder free, Blue)
Leping Shengde Medical Technology Company Limited, CN
LZA
Oct 27, 2021K211604Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Shanxi Hongjin Plastic Technology Co., Ltd., CN
LZA
Oct 26, 2021K212363Disposable Medical Nitrile Examination Gloves
Lanhuo Medical Technology (Jiangsu) Co.,Ltd, CN
LZA
Oct 25, 2021K212401Disposable Nitrile Examination Glove
Inner Mongolia Cureguard Medical Technology Co., Ltd., CN
LZA
Oct 25, 2021K210249Best Glove-Nitrile Powder Free Examination Glove
Bestsafe Glove Co., Ltd., TH
LZA
Oct 21, 2021K212311Medical Examination Gloves
Guangzhou Junda Gloves Co., Ltd., CN
LZA
Oct 19, 2021K210706Nitrile Examination Gloves
Niujian Technology Co., Ltd., CN
LZA
Oct 14, 2021K211914Nitrile Patient Examination Gloves
Yingxiang Glove Products Co., Ltd., CN
LZA
Oct 13, 2021K212014Medical Nitrile Examination Gloves
Jiangxi Ronglai Medical Technology Co., Ltd., CN
LZA
Oct 13, 2021K211374Proclean - Nitrile Powder Free Examination Gloves
Dr.Boo Company Limited, TH
LZA
Oct 12, 2021K211927Nitrile examination gloves
Fitone Latex Products Co., Ltd. Guangdong, CN
LZA
Oct 8, 2021K212078Medical Examination Gloves
Guangdong Gymda Medical Technology Co.,Ltd, CN
LZA
Oct 6, 2021K211719ZinRom Nitrile examination gloves
Changzhou Xingrong Medical Technology Co., Ltd., CN
LZA
Oct 5, 2021K212036Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
Jiangsu Yanfang Medical Technology Co., Ltd., CN
LZA
Sep 29, 2021K211781Disposable Nitrile Gloves
Jiangsu Jinke Protective Equipment Co., Ltd., CN
LZA
Sep 21, 2021K211073Disposable Nitrile Examination Gloves
Foshan Kangkang Biotechnology Co., Ltd., CN
LZA
Sep 16, 2021K211479Blue Nitrile Examination Glove Powder Free
Aspen Glove Sdn. Bhd., MY
LZA
Sep 15, 2021K212009Disposable Nitrile Gloves
Jiangsu Shenglijie Safety Products Co., Ltd., CN
LZA
Sep 2, 2021K211778Nitrile Examination Gloves, Green/ Blue/ Black Color
Zhenjiang Suhui Latex Products Co., Ltd., CN
LZA
Sep 2, 2021K210868Nitrile Examination Gloves Powder Free (Blue)
Great Eco Glove Sdn. Bhd., MY
LZA
Sep 1, 2021K211673Disposable Medical Nitrile Gloves
Changzhou Yihua Sanitation Material Co., Ltd., CN
LZA
Aug 28, 2021K211390Nitrile Blue Powder-free Examination Glove
Cardinal Health200, LLC
LZA
Aug 26, 2021K210898Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
Tangshan Lanhai Medical Supplies Co., Ltd., CN
LZA

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