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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
May 25, 2006K060726POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
Smart Glove Corp. Sdn Bhd, MY
LZA
May 24, 2006K061074ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
Bright Element Sdn Bhd, MY
LZA
May 23, 2006K061192BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
Ethicon Endo-Surgery, LLC
LZA
May 17, 2006K060724POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
Smart Glove Corp. Sdn Bhd, MY
LZA
May 1, 2006K060771POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
Kossan Latex Industries(M)Sdn Bhd, MY
LZA
May 1, 2006K060073TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
Shen Wei (Usa), Inc.
LZA
Apr 28, 2006K060147POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Hongye Plastic Products Co., Ltd.
LZA
Apr 27, 2006K060753NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
Siam Sempermed Corp., Ltd.
LZA
Apr 24, 2006K060733SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44
Barriermed, Inc.
LZA
Mar 30, 2006K053366NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
Pt Mahakarya Inti Buana, ID
LZA
Feb 13, 2006K053657POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
Pt Mahakarya Inti Buana, ID
LZA
Jan 19, 2006K052955NITRILE BLUE POWDERED EXAMINATION GLOVES
Great Glove Sdn Bhd, MY
LZA
Dec 21, 2005K052956NITRILE BLUE POWDER FREE EXAMINATION GLOVE
Great Glove Sdn Bhd, MY
LZA
Nov 30, 2005K052892SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
Barriermed Glove Co.
LZA
Nov 18, 2005K052502NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
Yty Industry (Manjung) Sdn Bhd
LZA
Nov 8, 2005K052877POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
Syntex Healthcare Products Co., Ltd.
LZA
Oct 31, 2005K052890NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
Siam Sempermed Corp., Ltd.
LZA
Sep 15, 2005K052382POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Pt.Shamrock Manufacturing Corp.
LZA
Aug 12, 2005K051777NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
Hartalega Sdn Bhd, MY
LZA
Aug 3, 2005K051378POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Medline
LZA
Jul 26, 2005K051778NITRILE POWDERED EXAMINATION GLOVES (BLUE)
Hartalega Sdn Bhd, MY
LZA
Jul 22, 2005K051662VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
Grand Work Plastic Products Co., Ltd., CN
LZA
Jul 22, 2005K051333NITRILE EXAMINATION GLOVES, POWDER FREE
Shun Thai Rubber Gloves Industry Co., Ltd., TH
LZA
Jul 12, 2005K050968POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
Pt. Medisafe Technologies, ID
LZA
Jul 7, 2005K051372POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
Platinum Glove Industries Sdn. Bhd., MY
LZA
Jun 20, 2005K051317POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR
Platinum Glove Industries Sdn. Bhd., MY
LZA
Jun 17, 2005K051318POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
Platinum Glove Industries Sdn. Bhd., MY
LZA
Jun 7, 2005K051347KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
Kimberly-Clark Corp.
LZA
May 25, 2005K043149FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)
Firstline, LLC
LZA
May 19, 2005K050528POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)
Spi Gloves Sdn. Bhd., MY
LZA
Apr 18, 2005K050122POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
Smart Glove Corp. Sdn Bhd, MY
LZA
Apr 8, 2005K050765LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
N.S. Uni-Gloves Sdn. Bhd.
LZA
Apr 7, 2005K050598POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
Smart Glove Corp. Sdn Bhd, MY
LZA
Mar 30, 2005K050467POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
Shen Wei (Usa), Inc.
LZA
Mar 18, 2005K050531POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)
Spi Gloves Sdn. Bhd., MY
LZA
Mar 16, 2005K050530POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)
Spi Gloves Sdn. Bhd., MY
LZA
Mar 16, 2005K050214NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
Hartalega Sdn Bhd, MY
LZA
Mar 11, 2005K050215NITRILE POWDERED EXAMINATION GLOVES (WHITE)
Hartalega Sdn Bhd, MY
LZA
Jan 18, 2005K042898PANTHERA N POWDER FREE BLACK NITRILE GLOVES
Glovco (M) Sdn. Bhd., MY
LZA
Jan 13, 2005K042879NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
Sgmp Co., Ltd.
LZA
Dec 16, 2004K042239FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
Pt. Mandiri Inti Buana, ID
LZA
Dec 6, 2004K042817MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
Ansell Healthcare Products, Inc.
LZA
Dec 1, 2004K041913POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
Pt. Medisafe Technologies, ID
LZA
Sep 30, 2004K042226SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
Syntex Healthcare Products Co., Ltd.
LZA
Sep 20, 2004K042378NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
Shijiazhuang Tillotson Rubber Products Co., Ltd.
LZA
Sep 16, 2004K042238CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
Seal Polymer Industries Bhd., MY
LZA
Aug 27, 2004K042101CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
Seal Polymer Industries Bhd., MY
LZA
Aug 20, 2004K041848POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
Pt. Smartglove Indonesia, ID
LZA
Aug 20, 2004K041276POWDER-FREE NITRILE EXAMINATION GLOVES
Shanghai Motex Healthcare Co., Ltd.
LZA
Jul 9, 2004K041391FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
Hartalega Sdn Bhd
LZA

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