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..
1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
Cleared
Mar 11, 2009
BIOCLEAN CHEMO SHIELD
Nitritex (M) Sdn. Bhd.
General Hospital
244d
Cleared
Mar 06, 2009
BLACK NITRILE EXAMINATION GLOVES
Innovative Gloves Co;, Ltd.
General Hospital
66d
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
Feb 10, 2009
N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
Best Glove, Inc.
General Hospital
172d
Cleared
Feb 10, 2009
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital
64d
Cleared
Jan 30, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
Gx Corporation Sdn Bhd
General Hospital
46d
Cleared
Jan 15, 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
Siam Sempermed Corp., Ltd.
General Hospital
196d
Cleared
Jan 07, 2009
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital
121d
Cleared
Dec 11, 2008
BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
Nitritex (M) Sdn. Bhd.
General Hospital
154d
Cleared
Dec 09, 2008
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
Pt. Medisafe Technologies
General Hospital
119d
Cleared
Dec 03, 2008
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Quality Gallant Sdn. Bhd.
General Hospital
180d
Cleared
Nov 21, 2008
N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT
Best Glove, Inc.
General Hospital
115d
Cleared
Nov 10, 2008
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
Ansell Healthcare Products, Inc.
General Hospital
76d
Cleared
Oct 17, 2008
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
Medline Industries, Inc.
General Hospital
133d
Cleared
Oct 17, 2008
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
Smart Glove Corp. Sdn Bhd
General Hospital
60d
Cleared
Sep 12, 2008
DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
Dynarex Corporation
General Hospital
100d
Cleared
Aug 11, 2008
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)
Gx Corporation Sdn Bhd
General Hospital
94d
Cleared
Jul 30, 2008
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Smart Glove Corp. Sdn Bhd
General Hospital
64d
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
Jun 19, 2008
MICRO-TOUCH NITRAFREE
Ansell Healthcare Products, LLC
General Hospital
113d
Cleared
May 23, 2008
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
Gx Corporation Sdn Bhd
General Hospital
51d
Cleared
May 14, 2008
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
Platinum Glove Industries Sdn. Bhd.
General Hospital
112d
Cleared
Apr 30, 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
Siam Sempermed Corp., Ltd.
General Hospital
65d