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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
Aug 3, 2012K121526POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
Shandong Junchi Medical Products Co., Ltd.
LZA
Aug 3, 2012K121192NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
Tekmedic (M) Sdn Bhd, MY
LZA
Jul 19, 2012K120970NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
Tangshan Zhonghong Pulin Plastic Co.,Ltd, CN
LZA
Jul 12, 2012K121529BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
Northstar Healthcare Holdings, IE
LZA
Jul 5, 2012K121464BLUE POWER FREE NITRILE EXAMINATION GLOVE
Northstar Healthcare Holdings, IE
LZA
Jul 3, 2012K121506UTB BLUE POWDER FREE NITRILE
Northstar Healthcare Holdings, IE
LZA
Jun 8, 2012K111718LANO-E
Ug Global Resources Sdn. Bhd.
LZA
May 23, 2012K113440HIGH FIVE
Central Medicare Sdn Bhd
LZA
May 8, 2012K113639C2 MEDICAL GLOVES
Amercare, Inc.
LZA
May 2, 2012K120184POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
Encompass Medical Supplies Inc Limited, CN
LZA
May 2, 2012K112924RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
Riverstone Resources Sdn Bhd, MY
LZA
Apr 19, 2012K111464PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
Dipped Products (Thailand), Ltd., TH
LZA
Apr 17, 2012K112928RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
Riverstone Resources Sdn Bhd, MY
LZA
Mar 21, 2012K112012NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
Ug Healthcare (Usa), Inc.
LZA
Mar 9, 2012K113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
Kimberly-Clark Corp.
LZA
Feb 6, 2012K113100POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Maxter Glove Manufacturing Sdn Bhd, MY
LZA
Feb 2, 2012K112976NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
Hartalega Snd. Bhd., MY
LZA
Jan 26, 2012K111134NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Siem Aempemed Corp., Ltd.
LZA
Dec 1, 2011K111248NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
Yty Industry (Manjung) Sdn Bhd
LZA
Oct 20, 2011K111772POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
Kossan Latex Industries(M)Sdn Bhd, MY
LZA
Oct 20, 2011K110979DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
Advanced Medical Products Sdn Bhd, MY
LZA
Oct 3, 2011K103675CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
Chienmax Vietnam Co., Ltd.
LZA
Aug 23, 2011K111589POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
Derma Care Plus Products, LLC
LZA
Aug 19, 2011K103734POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
Central Medicare Sdn Bhd
LZA
Aug 12, 2011K111300SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
Pt Mahakarya Inti Buana, ID
LZA
Aug 12, 2011K110758NITRILE POWDER FREE EXAMINATION GLOVES
Hartalega Sdn Bhd, MY
LZA
Jul 15, 2011K111328POWDER FREE NITRILE EXAMINATION GLOVES
Gx Corporation Sdn Bhd, MY
LZA
Jul 14, 2011K110960ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
Koon Seng Sdn Bhd
LZA
Jul 13, 2011K110418POWDER FREE NITRILE EXAMINATION GLOVES
W.A. Rubbermate Co., Ltd., TH
LZA
Jun 15, 2011K110297POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Jun 10, 2011K110248POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
Jiangsu Dongling Plastic & Rubber Co., Ltd., CN
LZA
Jun 10, 2011K110247POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
Jiangsu Dongling Plastic & Rubber Co., Ltd., CN
LZA
Jun 6, 2011K102623BLUE POWDERFREE NITRILE EXAMINATION GLOVE
Pt. Medisafe Technologies, ID
LZA
May 23, 2011K110155NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Tangshan Xiangrui Plastic Products Co., Ltd., CN
LZA
May 13, 2011K110146NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Tangshan Kaiyue Glove Co., Ltd., CN
LZA
May 13, 2011K110102POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
Preventive Care, Inc.
LZA
Apr 21, 2011K103770SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
Syntex Healthcare Products Co., Ltd.
LZA
Apr 15, 2011K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Cardinal Health, Inc.
LZA
Apr 4, 2011K110185NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Tangshan Baojie Glove Co., Ltd., CN
LZA
Mar 31, 2011K103670NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
Innovative Gloves Co;, Ltd., TH
LZA
Mar 23, 2011K103661RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
Rubbercare Protection Products Sdn Bhd, MY
LZA
Mar 17, 2011K102846PATIENT EXAMINATION GLOVES
Thai Hua Holding Co., Ltd.
LZA
Mar 3, 2011K101820NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
Yty Industry (Manjung) Sdn Bhd
LZA
Feb 25, 2011K103337MULTIPLE NAME
Ideal Quality Sdn., Bhd., MY
LZA
Dec 20, 2010K101870SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
Sunmax Vietnam Co., Ltd.
LZA
Dec 16, 2010K103249NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
Cardinal Health, Inc.
LZA
Nov 22, 2010K102620POWDERFREE BLACK NITRILE EXAMINATION GLOVES
Pt. Medisafe Technologies, ID
LZA
Nov 19, 2010K102880BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
Brightway Holdings Sdn. Bhd., MY
LZA
Nov 8, 2010K101943SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES
Tangshan Jiteng Plastic Products Co., Ltd.
LZA
Nov 2, 2010K102074POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
Gx Corporation Sdn Bhd, MY
LZA

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