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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
Jul 8, 2004K040841POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Medline Industries, Inc.
LZA
Jun 3, 2004K040791POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
Pt. Smartglove Indonesia, ID
LZA
Apr 22, 2004K040607MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
Pt. Medisafe Technologies, ID
LZA
Mar 15, 2004K034052BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Latexx Manufacturing Sdn.Bhd.
LZA
Mar 2, 2004K033887NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
Yty Industry (Manjung) Sdn Bhd
LZA
Feb 26, 2004K033086NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE
Pt. Medisafe Technologies, ID
LZA
Feb 24, 2004K040176MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
Maxter Glove Manufacturing Sdn Bhd, MY
LZA
Feb 5, 2004K033777ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
Syntex Healthcare Products Co., Ltd.
LZA
Jan 8, 2004K033683SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
Smart Glove Corp. Sdn Bhd, MY
LZA
Oct 29, 2003K032024POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Shen Wei (Usa), Inc.
LZA
Sep 23, 2003K031944VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
Arista Latindo Industrial Ltd. P.T, ID
LZA
Sep 8, 2003K032549MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
Matang Mfg. Sdn. Bhd.
LZA
Aug 19, 2003K032077CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
Seal Polymer Industries Bhd., MY
LZA
Aug 19, 2003K032011GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
Pt. Wrp Buana Multicorpora, ID
LZA
Aug 19, 2003K032010GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
Pt. Wrp Buana Multicorpora, ID
LZA
Aug 15, 2003K031157POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
Qingdao Bestex Rubber & Plastic Products Co., Ltd.
LZA
Aug 8, 2003K030529LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
Jda (Tianjin) Plastic Rubber Co., Ltd., CN
LZA
Aug 1, 2003K031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
Perusahaan Getah Asas Sdn. Bhd.
LZA
Aug 1, 2003K031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
Perusahaan Getah Asas Sdn. Bhd.
LZA
Jul 25, 2003K031580NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
Green Prospect Sdn Bhd
LZA
Jun 26, 2003K031591POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
Perusahaan Getah Asas Sdn. Bhd.
LZA
Jun 17, 2003K031384MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G
Yty Industry (Manjung) Sdn Bhd
LZA
May 2, 2003K030207NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
Shanghai Motex Healthcare Co., Ltd., CN
LZA
Apr 4, 2003K030245NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
Arista Latindo Industrial Ltd. P.T, ID
LZA
Mar 28, 2003K030386POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
Shamrock Manufacturing Company
LZA
Mar 25, 2003K030284POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
Pt. Smartglove Indonesia, ID
LZA
Mar 5, 2003K030075NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
Best Manufacturing Company-Distribution Center
LZA
Mar 3, 2003K030335ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
Perusahaan Getah Asas Sdn. Bhd.
LZA
Feb 27, 2003K030406NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
Pt. Smartglove Indonesia, ID
LZA
Feb 19, 2003K022814MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
Pt. Smartglove Indonesia, ID
LZA
Feb 13, 2003K023072POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
Arista Latindo Industrial Ltd. P.T, ID
LZA
Jan 24, 2003K023979NITRILE EXAMINATION GLOVES, PRE-POWDERED
Starmatrix Sdn Bhd, MY
LZA
Jan 24, 2003K023978NITRILE EXAMINATION GLOVES, POWDER FREE
Starmatrix Sdn Bhd, MY
LZA
Jan 14, 2003K024184POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
Perusahaan Getah Asas Sdn. Bhd.
LZA
Jan 10, 2003K024083GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Supermax Glove Manufacturing Sdn Bhd, MY
LZA
Dec 18, 2002K024025POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
Kossan Latex Industries(M)Sdn Bhd
LZA
Dec 18, 2002K023702POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
Ningbo Tianshun Rubber Products Co., Ltd.
LZA
Dec 2, 2002K023517DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Nov 18, 2002K022671FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
Hartalega Sdn Bhd
LZA
Nov 13, 2002K022784SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
Syntex Healthcare Products Co., Ltd., CN
LZA
Nov 8, 2002K022572NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
Ar Alliance Healthcare Sdn. Bhd., MY
LZA
Oct 25, 2002K023428VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
Shanghai Jiawang Industrial Co. , Ltd.
LZA
Oct 18, 2002K022346CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
Latexx Manufacturing Sdn.Bhd., MY
LZA
Oct 11, 2002K022765NITRILE POWDER-FREE EXAMINATION GLOVES
Allegiance Healthcare Corp.
LZA
Oct 9, 2002K023170NITRILE POWDER-FREE EXAMINATION GLOVES
Allegiance Healthcare Corp.
LZA
Oct 8, 2002K022781MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
Industrial Clothings, Ltd., LK
LZA
Oct 3, 2002K022904DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Sep 17, 2002K022878BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
Brightway Holdings Sdn. Bhd., MY
LZA
Sep 17, 2002K022818MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Smart Glove Corp. Sdn Bhd, MY
LZA
Sep 6, 2002K022619POWDER FREE NITRILE EXAMINATION GLOVES
Ar Alliance Healthcare Sdn. Bhd., MY
LZA

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