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Panels › General Hospital › Product code LZA · Class 1

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 23, 2019K190736Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
Ever Growth (Vietnam) Co. , Ltd., VN
LZA
Dec 17, 2019K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Riverstone Resources Sdn Bhd, MY
LZA
Dec 2, 2019K190876mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Mercator Medical (Thailand), Ltd., TH
LZA
Nov 8, 2019K192232Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
Hartalega NGC Sdn. Bhd., MY
LZA
Oct 4, 2019K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use
Semperit Investments Asia Pte , Ltd., SG
LZA
Sep 26, 2019K190466PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fent
Shen Wei USA, Inc.
LZA
Sep 26, 2019K190454Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powde
Hartalega NGC Sdn. Bhd., MY
LZA
Sep 16, 2019K191800Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitr
Kossan International Sdn Bhd, MY
LZA
Sep 6, 2019K190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free
Ever Global (Vietnam) Enterprise Corporation, VN
LZA
Jul 30, 2019K182089Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
Platinum Glove Industries Sdn. Bhd., MY
LZA
Jul 26, 2019K183280PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
Smart Glove Corporation Sdn. Bhd., MY
LZA
Jun 27, 2019K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Jun 26, 2019K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O&M Halyard, Inc.
LZA
Jun 20, 2019K183354Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
Gx Corporation Sdn Bhd, MY
LZA
May 30, 2019K182308Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
Sri Trang Gloves (Thailand) Co., Ltd., TH
LZA
May 28, 2019K190606Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Kossan International Sdn Bhd, MY
LZA
May 10, 2019K182612Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
Zibo Yahao Supplies Co., Ltd., CN
LZA
Apr 12, 2019K182640Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
Shandong Hengya Packaging Printing Co.,Ltd, CN
LZA
Apr 5, 2019K183287Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fen
Kossan International Sdn Bhd, MY
LZA
Mar 22, 2019K182554Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
He Chuang Plastic & Rubber Co., Ltd., CN
LZA
Mar 11, 2019K182241Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
Sri Trang Gloves (Thailand) Co., Ltd., TH
LZA
Jan 16, 2019K181106Powder Free Nitrile Patient Examination Gloves, Blue Color
Jiangsu Dongxin Medical Technology Co., Ltd., CN
LZA
Dec 21, 2018K183068Nitrile Glove Powder Free White
Haining Medical Products Co., Ltd., CN
LZA
Nov 30, 2018K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
Better Care Plastic Technology Co., Ltd., CN
LZA
Nov 20, 2018K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with
Kossan International Sdn Bhd, MY
LZA
Nov 16, 2018K180645Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
Hartalega Sdn Bhd, MY
LZA
Nov 15, 2018K182528Nitrile Glove Powder Free Black
Haining Medical Products Co., Ltd., CN
LZA
Nov 2, 2018K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
Owens & Minor Halyard, Inc.
LZA
Nov 2, 2018K180786Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile P
Hartalega Sdn Bhd, MY
LZA
Oct 10, 2018K180468SBG Black Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc.
LZA
Oct 10, 2018K180467SBG Blue Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc.
LZA
Sep 26, 2018K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs C
Eco Medi Glove Sdn. Bhd., MY
LZA
Aug 17, 2018K173509Biodegradable Nitrile Powder Free Examination Glove (Blue)
Hartalega Sdn Bhd, MY
LZA
Aug 10, 2018K180644Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
Hartalega Sdn Bhd, MY
LZA
Jul 5, 2018K161085Nitrile Patient Examination Powder Free Glove, Textured, Black
Multisafe Sdn. Bhd., MY
LZA
Jun 14, 2018K180505Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use
Hartalega Sdn Bhd, MY
LZA
Jun 12, 2018K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
Riverstone Resources Sdn Bhd, MY
LZA
Jun 11, 2018K171422Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
Ever Global (Vietnam) Enterprise Corp, VN
LZA
May 10, 2018K172867Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
Gmp Medicare Sdn Bhd (F25), MY
LZA
Apr 30, 2018K180696Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemothera
Medline Industries, Inc.
LZA
Apr 26, 2018K172923Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With
Top Glove Sdn. Bhd., MY
LZA
Apr 13, 2018K172930mCare Powder-free Blue Nitrile Examination Gloves
Mercator Medical (Thailand), Ltd., TH
LZA
Feb 22, 2018K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
Koon Seng Sdn Bhd, MY
LZA
Feb 20, 2018K173228U-MED Powder Free Polyethylene Examination Gloves,Blue Color
Jiangsu U-Med Rubber & Plastic Products Co., Ltd., CN
LZA
Dec 29, 2017K171737Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
Ansell Healthcare Products, LLC
LZA
Dec 12, 2017K173137Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
Hartalega Sdn Bhd, MY
LZA
Nov 24, 2017K172678THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
Shen Wei USA, Inc.
LZA
Nov 17, 2017K171743Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination G
Smart Glove Corporation Sdn. Bhd., MY
LZA
Nov 15, 2017K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs
Zhonghong Pulin Medical Products Co., Ltd., CN
LZA
Nov 6, 2017K172442Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Bl
Hartalega NGC Sdn. Bhd., MY
LZA

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