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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
Oct 15, 2010K101351NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
Ascend Eagle, Inc.
LZA
Oct 8, 2010K101594POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Better Care Plastic Technology Cp., Ltd.
LZA
Oct 6, 2010K101760ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
Profit Point Manufacturing Sdn Bhd, MY
LZA
Oct 4, 2010K102096POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Syntex Healthcare Products Co., Ltd.
LZA
Sep 10, 2010K102230NUGARD NITILE GREY COLOR
Terang Nusa Sdn Bhd, MY
LZA
Sep 8, 2010K102032KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
Kimberly-Clark Corp.
LZA
Sep 8, 2010K101646NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
Sgmp Co., Ltd.
LZA
Sep 7, 2010K101630POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
Pt. Smartglove Indonesia, ID
LZA
Aug 17, 2010K100975NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
Jiangsu Sunshine Plastic Products, Co., Ltd., TW
LZA
Aug 6, 2010K101595POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Better Care Plastic Technology Cp., Ltd.
LZA
Jul 16, 2010K100603RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
Riverstone Resources Sdn Bhd, MY
LZA
Jul 2, 2010K100979NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
Jiangsu Sunshine Plastic Products, Co., Ltd., TW
LZA
Jul 1, 2010K101293POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
Pt. Smartglove Indonesia, ID
LZA
Jun 29, 2010K093517NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE
Summit Glove, Inc.
LZA
Jun 29, 2010K093516NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
Summit Glove, Inc.
LZA
Jun 22, 2010K092874POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
Quality Gallant Sdn. Bhd., MY
LZA
Jun 18, 2010K093335LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
La Glove (M) Sdn. Bhd., MY
LZA
May 20, 2010K100369POWDER-FREE NITRILE GLOVES, BLACK
Hl Rubber Industries Sdn Bhd, MY
LZA
May 20, 2010K092617ROYAL GUARD
Shun Thai Rubber Gloves Industry Public Co., Ltd.
LZA
Apr 15, 2010K092472NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
Ascend Eagle, Inc.
LZA
Mar 24, 2010K100162MULTIPLE PRIVATE LABEL
Biogreen Yields Sdn.Bhd, MY
LZA
Mar 4, 2010K093523MICRO-TOUCH NITRILE
Ansell Healthcare Products, LLC
LZA
Feb 22, 2010K093726MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Medline Industries, Inc.
LZA
Feb 19, 2010K093759MULTIPLE NAME MODEL MULTIPLE
Gx Corporation Sdn Bhd (Plant 1), MY
LZA
Feb 12, 2010K093696SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
Central Medicare Sdn Bhd
LZA
Dec 28, 2009K091851STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Gx Corporation Sdn Bhd, MY
LZA
Nov 27, 2009K092160POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
Comfort Rubber Gloves Ind. Sdn. Bhd., MY
LZA
Nov 24, 2009K091965POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED
Platinum Glove Industries Sdn. Bhd., MY
LZA
Nov 20, 2009K092498LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
La Glove (M) Sdn. Bhd., MY
LZA
Nov 4, 2009K092072POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
Gx Corporation Sdn Bhd, MY
LZA
Oct 21, 2009K092411PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
Shen Wei (Usa), Inc.
LZA
Oct 19, 2009K092034POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
Pt. Smartglove Indonesia, ID
LZA
Oct 2, 2009K090568MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
Medline Industries, Inc.
LZA
Sep 21, 2009K092327MICRO-TOUCH NITRA FREE
Ansell Healthcare Products, LLC
LZA
Sep 16, 2009K092200POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
Gx Corporation Sdn Bhd, MY
LZA
Sep 4, 2009K091652NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
Hartalega Sdn Bhd, MY
LZA
Jul 28, 2009K090828NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
Ultrawin Sdn Bhd, MY
LZA
Jul 27, 2009K091147POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
Smart Glove Corp. Sdn Bhd, MY
LZA
Jul 7, 2009K090194POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
Shen Wei (Usa), Inc.
LZA
Jul 1, 2009K090336SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
Sunmax Enterprise Shanghai Co. , Ltd.
LZA
Jun 1, 2009K091151POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
Gx Corporation Sdn Bhd, MY
LZA
Jun 1, 2009K090412POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
Gx Corporation Sdn Bhd, MY
LZA
May 29, 2009K082957NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
Siam Sempermed Corp., Ltd.
LZA
May 8, 2009K083156NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Giga-Drive Sdn, Bhd, MY
LZA
Apr 23, 2009K090464BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
Pt Mahakarya Inti Buana, ID
LZA
Mar 11, 2009K081970BIOCLEAN CHEMO SHIELD
Nitritex (M) Sdn. Bhd., MY
LZA
Mar 6, 2009K083908BLACK NITRILE EXAMINATION GLOVES
Innovative Gloves Co;, Ltd., TH
LZA
Mar 5, 2009K083755NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
Siam Sempermed Corp., Ltd.
LZA
Feb 10, 2009K083624POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Comfort Rubber Gloves Ind. Sdn. Bhd., MY
LZA
Feb 10, 2009K082428N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
Best Glove, Inc.
LZA

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