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Panels › General Hospital › Product code LZA · Class 1

Polymer Patient Examination Glove

Regulation 880.6250

16510(k)s in 12 months (1,181 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
Jul 4, 2023K231740MemorialTM Gloves
Us Glove Supply
LZA
Jun 9, 2023K230779Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Shanxi Hongjin Plastic Technology Co., Ltd., CN
LZA
Jun 6, 2023K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
Nephron Nitrile, LLC
LZA
Jun 5, 2023K230633APOLLO ADVANTAGE Nitrile Examination Gloves
Dell Corning Corporation
LZA
May 31, 2023K230542Disposable Nitrile Gloves (ABC-DG01)
Huizhou Anboson Technology Co., Ltd., CN
LZA
May 30, 2023K230958First Glove Blue Nitrile Examination Gloves Powder Free
First Glove Sdn. Bhd., MY
LZA
May 28, 2023K230601Blue Nitrile Examination Gloves Powder Free
Latrile Gloves Private Limited, IN
LZA
May 23, 2023K230564Green Non Sterile Powder Free Nitrile Examination Gloves
Central Medicare Sdn Bhd, MY
LZA
May 17, 2023K223437Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion
Hartalega NGC Sdn. Bhd., MY
LZA
May 15, 2023K230121Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Careglove Global Sdn. Bhd., MY
LZA
May 8, 2023K223280Disposible Nitrile Gloves
Holik Asia Group Co.,Ltd, CN
LZA
Apr 27, 2023K221983Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Bl
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
LZA
Mar 30, 2023K220088Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Professional Latex Sdn Bhd, MY
LZA
Mar 25, 2023K220644Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for
Yty Industry (Manjung) Sdn Bhd, MY
LZA
Mar 24, 2023K230002Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
Mah Sing Healthcare Sdn. Bhd., MY
LZA
Mar 23, 2023K223895Disposable Medical Nitrile Examination Gloves
Hebei Titans Hongsen Medical Technology Co., Ltd., CN
LZA
Mar 16, 2023K222813Nitrile Examination Gloves
Ecoglove Medical Manufacturing Company Limited, VN
LZA
Mar 15, 2023K223375Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with
Kossan International Sdn Bhd3, MY
LZA
Mar 15, 2023K223102Tegamen Nitrile Examination Gloves
M/S Tegamen Safety Products Private Limited, CA
LZA
Feb 13, 2023K223859Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
Rhino Health, Inc.
LZA
Feb 10, 2023K222129Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance
Top Glove Medical (Thailand) Co., Ltd., TH
LZA
Feb 9, 2023K223559Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
Nephron Pharmaceuticals Corporation
LZA
Feb 6, 2023K223444Powder Free Blue Nitrile Examination Glove
S&S Glove Corporation, VN
LZA
Jan 27, 2023K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL
Semperit Investments Asia Pte , Ltd., SG
LZA
Jan 26, 2023K223415Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Ci
Mah Sing Healthcare Sdn. Bhd., MY
LZA
Jan 22, 2023K222531Synthetic Polymer Glove - Polyethylene (Black)
Ur Industry Sdn Bhd, MY
LZA
Jan 19, 2023K223250Disposable Nitrile Examination Glove
Yangzhou Saraguard Medical Supplies Co., Ltd., CN
LZA
Jan 13, 2023K223748Nitrile Exam Gloves (Chemotherapy Drug Tested)
Us Medical Glove Company, LLC
LZA
Jan 13, 2023K223221Non-Sterile Powder Free Nitrile Examination Gloves
Dynacare Sdn Bhd, MY
LZA
Jan 11, 2023K222181Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Iconic Medicare Sdn Bhd, MY
LZA
Jan 4, 2023K222907Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Rmkh Glove (Cambodia) Co., Ltd., KH
LZA
Dec 15, 2022K222892Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
Grand Work Plastic Products Co., Ltd., CN
LZA
Dec 14, 2022K222527Nitrile Patient Examination Glove
Pingan Medical Products Co., Ltd., CN
LZA
Dec 11, 2022K222733Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
Inner Mongolia Boming Medical Supplies Co., Ltd., CN
LZA
Dec 7, 2022K223281Disposable Nitrile Examination Glove
Anhui Kindguard Medical Supplies Technology Co., Ltd., CN
LZA
Dec 7, 2022K221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
LZA
Dec 4, 2022K223004Disposable Nitrile Examination Gloves
Jiangxi Handspro Products Solutions Co., Ltd., CN
LZA
Dec 4, 2022K222815Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
Zibo Lanhua Medical Packaging Material Co., Ltd., CN
LZA
Dec 3, 2022K222720Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited, CN
LZA
Dec 3, 2022K222715Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited, CN
LZA
Dec 3, 2022K222713White Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited, CN
LZA
Dec 1, 2022K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Fitone Latex Products Co., Ltd. Guangdong, CN
LZA
Nov 30, 2022K221082Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentan
Rhino Health, Inc.
LZA
Nov 23, 2022K222534Nitrile Patient Examination Glove
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd., CN
LZA
Nov 20, 2022K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and N
Sri Trang Gloves (Thailand) Public Company Limited, TH
LZA
Nov 12, 2022K213981Nitrile Examination Gloves
Emerald Glove Manufacturing Sdn Bhd, MY
LZA
Nov 11, 2022K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
Hartalega NGC Sdn. Bhd., MY
LZA
Nov 7, 2022K222898SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
Safesource Direct, LLC
LZA
Nov 2, 2022K223320Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Lingshi Hongruida Health Protection Technology Co., Ltd., CN
LZA
Nov 2, 2022K220371Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for
Summit Glove, Inc.
LZA

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