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
Cleared
Oct 21, 2009
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
Shen Wei (Usa), Inc.
General Hospital
75d
Cleared
Oct 02, 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
Medline Industries, Inc.
General Hospital
213d
Cleared
Sep 04, 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
Hartalega Sdn Bhd
General Hospital
87d
Cleared
Jul 07, 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
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
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
Siam Sempermed Corp., Ltd.
General Hospital
78d
Cleared
Jan 15, 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
Siam Sempermed Corp., Ltd.
General Hospital
196d
Cleared
Oct 17, 2008
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
Medline Industries, Inc.
General Hospital
133d
Cleared
Jul 09, 2008
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
Kimberly-Clark Corp.
General Hospital
68d
Cleared
Jun 30, 2008
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
Kimberly-Clark Corp.
General Hospital
81d
Cleared
Apr 30, 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
Siam Sempermed Corp., Ltd.
General Hospital
65d
Cleared
Mar 27, 2008
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
Sgmp Co., Ltd.
General Hospital
213d
Cleared
Sep 06, 2007
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
Hartalega Sdn Bhd
General Hospital
57d
Cleared
Jun 15, 2007
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
Siam Sempermed Corp., Ltd.
General Hospital
100d
Cleared
Apr 19, 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
Shen Wei (Usa), Inc.
General Hospital
302d
Cleared
Mar 20, 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
Shen Wei (Usa), Inc.
General Hospital
173d
Cleared
Nov 17, 2006
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
Hartalega Sdn Bhd
General Hospital
44d
Cleared
Sep 06, 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
Shen Wei (Usa), Inc.
General Hospital
47d
Cleared
Jun 14, 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
Hartalega Sdn Bhd
General Hospital
267d
Cleared
May 23, 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
Ethicon Endo-Surgery, LLC
General Hospital
25d
Cleared
May 01, 2006
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
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)
Siam Sempermed Corp., Ltd.
General Hospital
37d
Cleared
Oct 31, 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
Siam Sempermed Corp., Ltd.
General Hospital
18d
Cleared
Aug 12, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
Hartalega Sdn Bhd
General Hospital
42d