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..

1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
721–744 of 1181
Cleared Mar 04, 2010
MICRO-TOUCH NITRILE
K093523
Ansell Healthcare Products, LLC
General Hospital · 111d
Cleared Feb 22, 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726
Medline Industries, Inc.
General Hospital · 81d
Cleared Feb 19, 2010
MULTIPLE NAME MODEL MULTIPLE
K093759
Gx Corporation Sdn Bhd (Plant 1)
General Hospital · 74d
Cleared Feb 12, 2010
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
K093696
Central Medicare Sdn Bhd
General Hospital · 74d
Cleared Dec 28, 2009
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K091851
Gx Corporation Sdn Bhd
General Hospital · 189d
Cleared Nov 27, 2009
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092160
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital · 134d
Cleared Nov 24, 2009
POWDER FREE NITRILE EXAMINATION GLOVES BLACK
K091965
Platinum Glove Industries Sdn. Bhd.
General Hospital · 146d
Cleared Nov 20, 2009
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
K092498
La Glove (M) Sdn. Bhd.
General Hospital · 98d
Cleared Nov 04, 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
K092072
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)
K092411
Shen Wei (Usa), Inc.
General Hospital · 75d
Cleared Oct 19, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
K092034
Pt. Smartglove Indonesia
General Hospital · 105d
Cleared Oct 02, 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
K090568
Medline Industries, Inc.
General Hospital · 213d
Cleared Sep 21, 2009
MICRO-TOUCH NITRA FREE
K092327
Ansell Healthcare Products, LLC
General Hospital · 48d
Cleared Sep 16, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
K092200
Gx Corporation Sdn Bhd
General Hospital · 56d
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 28, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
K090828
Ultrawin Sdn Bhd
General Hospital · 124d
Cleared Jul 27, 2009
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K091147
Smart Glove Corp. Sdn Bhd
General Hospital · 98d
Cleared Jul 07, 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
K090194
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
K090336
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 141d
Cleared Jun 01, 2009
POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
K090412
Gx Corporation Sdn Bhd
General Hospital · 103d
Cleared Jun 01, 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
K091151
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
K082957
Siam Sempermed Corp., Ltd.
General Hospital · 238d
Cleared May 08, 2009
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K083156
Giga-Drive Sdn, Bhd
General Hospital · 196d
Cleared Apr 23, 2009
BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
K090464
Pt Mahakarya Inti Buana
General Hospital · 59d