LZA · Class I · 21 CFR 880.6250

FDA Product Code LZA: Polymer Patient Examination Glove

Examination gloves are among the most used medical devices in healthcare settings. FDA product code LZA covers polymer patient examination gloves — including nitrile, vinyl, and other synthetic materials.

These gloves provide a protective barrier between healthcare workers and patients during examination and non-surgical procedures. Nitrile gloves are the preferred choice for latex-sensitive patients and clinicians.

LZA devices are Class I medical devices, regulated under 21 CFR 880.6250 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Shen Wei (Usa), Inc., Hartalega Sdn Bhd and Hartalega NGC Sdn. Bhd..

1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
529–552 of 1175
Cleared Oct 21, 2009
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K092411
Shen Wei (Usa), Inc.
General Hospital · 75d
Cleared Oct 02, 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
K090568
Medline Industries, Inc.
General Hospital · 213d
Cleared Sep 04, 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
K091652
Hartalega Sdn Bhd
General Hospital · 87d
Cleared Jul 07, 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
K090194
Shen Wei (Usa), Inc.
General Hospital · 161d
Cleared May 29, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
K082957
Siam Sempermed Corp., Ltd.
General Hospital · 238d
Cleared Mar 05, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755
Siam Sempermed Corp., Ltd.
General Hospital · 78d
Cleared Jan 15, 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
K081911
Siam Sempermed Corp., Ltd.
General Hospital · 196d
Cleared Oct 17, 2008
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594
Medline Industries, Inc.
General Hospital · 133d
Cleared Jul 09, 2008
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
K081260
Kimberly-Clark Corp.
General Hospital · 68d
Cleared Jun 30, 2008
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
K081027
Kimberly-Clark Corp.
General Hospital · 81d
Cleared Apr 30, 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
K080520
Siam Sempermed Corp., Ltd.
General Hospital · 65d
Cleared Mar 27, 2008
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
K072400
Sgmp Co., Ltd.
General Hospital · 213d
Cleared Sep 06, 2007
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
K071910
Hartalega Sdn Bhd
General Hospital · 57d
Cleared Jun 15, 2007
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
K070639
Siam Sempermed Corp., Ltd.
General Hospital · 100d
Cleared Apr 19, 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
K061756
Shen Wei (Usa), Inc.
General Hospital · 302d
Cleared Mar 20, 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919
Shen Wei (Usa), Inc.
General Hospital · 173d
Cleared Nov 17, 2006
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
K063046
Hartalega Sdn Bhd
General Hospital · 44d
Cleared Sep 06, 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067
Shen Wei (Usa), Inc.
General Hospital · 47d
Cleared Jun 14, 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583
Hartalega Sdn Bhd
General Hospital · 267d
Cleared May 23, 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192
Ethicon Endo-Surgery, LLC
General Hospital · 25d
Cleared May 01, 2006
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
K060073
Shen Wei (Usa), Inc.
General Hospital · 112d
Cleared Apr 27, 2006
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
K060753
Siam Sempermed Corp., Ltd.
General Hospital · 37d
Cleared Oct 31, 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890
Siam Sempermed Corp., Ltd.
General Hospital · 18d
Cleared Aug 12, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
K051777
Hartalega Sdn Bhd
General Hospital · 42d