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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
Jan 30, 2009K083717POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
Gx Corporation Sdn Bhd, MY
LZA
Jan 15, 2009K081911NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
Siam Sempermed Corp., Ltd.
LZA
Jan 7, 2009K082598POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
Tangshan Zhonghong Pulin Group Co., Ltd., CN
LZA
Dec 11, 2008K081972BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
Nitritex (M) Sdn. Bhd., MY
LZA
Dec 9, 2008K082302POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
Pt. Medisafe Technologies, ID
LZA
Dec 3, 2008K081592POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Quality Gallant Sdn. Bhd., MY
LZA
Nov 21, 2008K082125N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT
Best Glove, Inc.
LZA
Nov 10, 2008K082457MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
Ansell Healthcare Products, Inc.
LZA
Oct 17, 2008K082370POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
Smart Glove Corp. Sdn Bhd, MY
LZA
Oct 17, 2008K081594MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
Medline Industries, Inc.
LZA
Sep 12, 2008K081569DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
Dynarex Corporation
LZA
Aug 11, 2008K081315POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)
Gx Corporation Sdn Bhd, MY
LZA
Jul 30, 2008K081466STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Smart Glove Corp. Sdn Bhd, MY
LZA
Jul 9, 2008K081260KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
Kimberly-Clark Corp.
LZA
Jun 30, 2008K081027KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
Kimberly-Clark Corp.
LZA
Jun 19, 2008K080536MICRO-TOUCH NITRAFREE
Ansell Healthcare Products, LLC
LZA
May 23, 2008K080937POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
Gx Corporation Sdn Bhd, MY
LZA
May 14, 2008K080165SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
Platinum Glove Industries Sdn. Bhd., MY
LZA
Apr 30, 2008K080520NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
Siam Sempermed Corp., Ltd.
LZA
Mar 27, 2008K072400NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
Sgmp Co., Ltd.
LZA
Mar 5, 2008K080066VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
Gx Corporation Sdn Bhd, MY
LZA
Oct 4, 2007K071740CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
Medtexx Manufacturing Sdn. Bhd., MY
LZA
Sep 14, 2007K071170POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
Smart Glove Corp. Sdn Bhd, MY
LZA
Sep 6, 2007K071910NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
Hartalega Sdn Bhd, MY
LZA
Aug 30, 2007K071072SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
Shanghai China Star Corp
LZA
Aug 7, 2007K071207MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
High Momentum Sdn Bhd, MY
LZA
Jul 30, 2007K071208MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES
High Momentum Sdn Bhd, MY
LZA
Jul 24, 2007K071119POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)
Gx Corporation Sdn Bhd, MY
LZA
Jun 15, 2007K070639NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
Siam Sempermed Corp., Ltd.
LZA
May 30, 2007K070862POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE)
Purtech Cleanroom Products Co., Ltd.
LZA
May 15, 2007K070861POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Hong Xin Rubber Products Co., Ltd.
LZA
Apr 19, 2007K061756TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
Shen Wei (Usa), Inc.
LZA
Apr 9, 2007K061505POWERED NITRILE BLUE EXAMINATION GLOVES
Liwe Trading, MY
LZA
Mar 26, 2007K070404NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Tangshan Luxiong Plastic Products Co., Ltd., CN
LZA
Mar 23, 2007K070097POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
Gx Corporation Sdn Bhd, MY
LZA
Mar 20, 2007K063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
Smart Glove Corp. Sdn Bhd, MY
LZA
Mar 20, 2007K062919TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
Shen Wei (Usa), Inc.
LZA
Mar 19, 2007K061504POWDER FREE NITRILE BLUE EXAMINATION GLOVE
Liwe Trading, MY
LZA
Mar 14, 2007K070096POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
Gx Corporation Sdn Bhd, MY
LZA
Feb 23, 2007K063777ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
Bright Element Sdn Bhd, MY
LZA
Feb 8, 2007K063522POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
Hl Rubber Industries Sdn Bhd, MY
LZA
Jan 23, 2007K063524POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
Hl Rubber Industries Sdn Bhd, MY
LZA
Nov 17, 2006K063046NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
Hartalega Sdn Bhd, MY
LZA
Oct 27, 2006K062778STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
Wear Safe Malaysia Sdn. Bhd., MY
LZA
Oct 5, 2006K062138POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
Molnlycke Health Care, Inc.
LZA
Sep 6, 2006K062067TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
Shen Wei (Usa), Inc.
LZA
Jul 25, 2006K061724POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
Smart Glove Corp. Sdn Bhd, MY
LZA
Jul 17, 2006K061553NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
Yty Industry (Manjung) Sdn Bhd
LZA
Jun 14, 2006K052583BLUE POWDER FREE NITRILE EXAMINATION GLOVES
Hartalega Sdn Bhd, MY
LZA
Jun 9, 2006K060402BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
Brightway Holdings Sdn. Bhd., MY
LZA

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