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 04, 2010
MICRO-TOUCH NITRILE
Ansell Healthcare Products, LLC
General Hospital
111d
Cleared
Feb 22, 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Medline Industries, Inc.
General Hospital
81d
Cleared
Feb 19, 2010
MULTIPLE NAME MODEL MULTIPLE
Gx Corporation Sdn Bhd (Plant 1)
General Hospital
74d
Cleared
Feb 12, 2010
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
Central Medicare Sdn Bhd
General Hospital
74d
Cleared
Dec 28, 2009
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Gx Corporation Sdn Bhd
General Hospital
189d
Cleared
Nov 27, 2009
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital
134d
Cleared
Nov 24, 2009
POWDER FREE NITRILE EXAMINATION GLOVES BLACK
Platinum Glove Industries Sdn. Bhd.
General Hospital
146d
Cleared
Nov 20, 2009
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
La Glove (M) Sdn. Bhd.
General Hospital
98d
Cleared
Nov 04, 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
Gx Corporation Sdn Bhd
General Hospital
119d
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 19, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
Pt. Smartglove Indonesia
General Hospital
105d
Cleared
Oct 02, 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
Medline Industries, Inc.
General Hospital
213d
Cleared
Sep 21, 2009
MICRO-TOUCH NITRA FREE
Ansell Healthcare Products, LLC
General Hospital
48d
Cleared
Sep 16, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
Gx Corporation Sdn Bhd
General Hospital
56d
Cleared
Sep 04, 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
Hartalega Sdn Bhd
General Hospital
87d
Cleared
Jul 28, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
Ultrawin Sdn Bhd
General Hospital
124d
Cleared
Jul 27, 2009
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
Smart Glove Corp. Sdn Bhd
General Hospital
98d
Cleared
Jul 07, 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
Shen Wei (Usa), Inc.
General Hospital
161d
Cleared
Jul 01, 2009
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital
141d
Cleared
Jun 01, 2009
POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
Gx Corporation Sdn Bhd
General Hospital
103d
Cleared
Jun 01, 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
Gx Corporation Sdn Bhd
General Hospital
42d
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
May 08, 2009
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Giga-Drive Sdn, Bhd
General Hospital
196d
Cleared
Apr 23, 2009
BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
Pt Mahakarya Inti Buana
General Hospital
59d