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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 26, 2014K141021POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
Hl Rubber Industries Sdn Bhd, MY
LZA
Aug 8, 2014K133325BLUE NITRILE POWDER FREE EXAM GLOVES
Shandong Xinshi Medical Products Co., Ltd.
LZA
Aug 7, 2014K133168DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Jul 24, 2014K140890NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
Hartalega NGC Sdn. Bhd., MY
LZA
Jul 18, 2014K133699POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
Pt. Smartglove Indonesia, ID
LZA
Jul 11, 2014K140316EXAMINATION GLOVES
Hl Rubber Industries Sdn Bhd, MY
LZA
Jul 8, 2014K140816POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
Better Care Plastic Technology Co., Ltd.
LZA
Jul 3, 2014K133689POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
Pt. Medisafe Technologies, ID
LZA
Jun 30, 2014K132354POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE
Advanced Health Products, Lot 60 & 61, MY
LZA
Jun 23, 2014K133193RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
Riverstone Resources Sdn Bhd, MY
LZA
Jun 20, 2014K140610NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
Hartalega NGC Sdn. Bhd., MY
LZA
Jun 2, 2014K133478POWDER FREE POLYETHYLENE EXAMINATION GLOVES
Shijiazhuang Hongzan Plastic Technology Co.,Ltd
LZA
May 30, 2014K133123NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
Yty Industry (Manjung) Sdn Bhd
LZA
May 28, 2014K133956NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
Hartalega Sdn Bhd, MY
LZA
Apr 8, 2014K133949POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Top Calibre Sdn Bhd, MY
LZA
Dec 13, 2013K132484DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Nov 7, 2013K132006STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
Hartalega Sdn Bhd, MY
LZA
Nov 7, 2013K131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
Kimberly-Clark Corp.
LZA
Sep 25, 2013K131440POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Hebei Hongsen Plastics Technology Co, Ltd.
LZA
Aug 8, 2013K130846MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN
Industrial Clothings, Ltd., LK
LZA
Jul 5, 2013K130473NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
Hartalega Sdn Bhd, MY
LZA
Apr 12, 2013K122464MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
Industrial Clothings, Ltd., LK
LZA
Apr 5, 2013K122453MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
Industrial Clothings, Ltd., LK
LZA
Mar 1, 2013K123749POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
Kossan Latex Industries(M)Sdn Bhd, MY
LZA
Feb 28, 2013K123869POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
Dehai (Shandong) Medical Gloves, Co., Ltd.
LZA
Feb 22, 2013K122727BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
Northstar Healthcare Holdings, IE
LZA
Feb 21, 2013K130038POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
Hl Rubber Industries Sdn Bhd, MY
LZA
Feb 19, 2013K123469POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
Wear Safe (Malaysia) Sdn Bhd - Facility II, MY
LZA
Feb 11, 2013K123116CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
Worldmed Manufacturing Sdn. Bhd., MY
LZA
Feb 8, 2013K123488LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
Puyang Linshi Health Co., Ltd.
LZA
Jan 31, 2013K122696POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
Cardinal Health, Inc.
LZA
Jan 28, 2013K123760MULTIPLE NAME
Assurguard Sdn. Bhd., MY
LZA
Jan 18, 2013K123328POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
Nitrilist Gloves Manufacturing Sdn Bhd, MY
LZA
Jan 18, 2013K121592POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
Tekmedic (M) Sdn Bhd, MY
LZA
Jan 17, 2013K122408POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
Hongye Plastic Products Co., Ltd.
LZA
Dec 27, 2012K121549NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
Siam Sempermed Corp., Ltd.
LZA
Dec 10, 2012K122874POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
Nitrilist Gloves Manufacturing Sdn Bhd, MY
LZA
Nov 30, 2012K122999POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Top Glove Sdn. Bhd., MY
LZA
Nov 16, 2012K120066POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
Kossan Latex Industries(M)Sdn Bhd, MY
LZA
Nov 6, 2012K122998BLUE POWDERED NITRILE EXAMINATION GLOVE
Northstar Healthcare Holdings
LZA
Oct 17, 2012K122131POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
Matang Mfg. Sdn. Bhd., MY
LZA
Oct 16, 2012K122465MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
Industrial Clothings, Ltd., LK
LZA
Oct 16, 2012K121992POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
Xinwei (Shandong) Plastic and Rubber Products Co.,
LZA
Oct 4, 2012K120110ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
Profit Point Manufacturing Sdn Bhd, MY
LZA
Sep 11, 2012K121528POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
Shen Wei (Usa), Inc.
LZA
Sep 11, 2012K113393POWDER FREE BLACK NITRILE EXAMINATION GLOVES
Tg Medical Sdn. Bhd., MY
LZA
Sep 10, 2012K122363NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Siam Sempermed Corp., Ltd.
LZA
Sep 10, 2012K121947ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
Northstar Healthcare Holdings, IE
LZA
Aug 17, 2012K120890POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
Shen Wei (Usa), Inc.
LZA
Aug 10, 2012K121368NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
Matang Mfg. Sdn. Bhd., MY
LZA

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