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
889–912 of 1181
Cleared Nov 13, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
K022784
Syntex Healthcare Products Co., Ltd.
General Hospital · 83d
Cleared Nov 08, 2002
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
K022572
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 98d
Cleared Oct 25, 2002
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
K023428
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 14d
Cleared Oct 18, 2002
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
K022346
Latexx Manufacturing Sdn.Bhd.
General Hospital · 91d
Cleared Oct 11, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765
Allegiance Healthcare Corp.
General Hospital · 52d
Cleared Oct 09, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Oct 08, 2002
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K022781
Industrial Clothings, Ltd.
General Hospital · 47d
Cleared Oct 03, 2002
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K022904
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 30d
Cleared Sep 17, 2002
MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K022818
Smart Glove Corp. Sdn Bhd
General Hospital · 22d
Cleared Sep 17, 2002
BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
K022878
Brightway Holdings Sdn. Bhd.
General Hospital · 18d
Cleared Sep 06, 2002
POWDER FREE NITRILE EXAMINATION GLOVES
K022619
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 30d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
K022090
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Aug 22, 2002
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
K022102
Latexx Manufacturing Sdn.Bhd.
General Hospital · 55d
Cleared Aug 15, 2002
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
K022347
Latexx Manufacturing Sdn.Bhd.
General Hospital · 27d
Cleared Aug 15, 2002
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
K022548
Latexx Manufacturing Sdn.Bhd.
General Hospital · 14d
Cleared Aug 12, 2002
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
K021668
Innovative Gloves Co;, Ltd.
General Hospital · 83d
Cleared Aug 09, 2002
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE
K022095
Wilshire Technologies
General Hospital · 43d
Cleared Aug 02, 2002
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
K022101
Latexx Manufacturing Sdn.Bhd.
General Hospital · 35d
Cleared Aug 01, 2002
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
K021452
Maxxim Medical
General Hospital · 87d
Cleared Aug 01, 2002
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
K022024
Best Manufacturing Company
General Hospital · 42d
Cleared Jul 05, 2002
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
K021730
Glovco (M) Sdn. Bhd.
General Hospital · 42d
Cleared Jun 10, 2002
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
K021743
Copioumed Intl., Inc.
General Hospital · 13d
Cleared Jun 06, 2002
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K021220
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Jun 06, 2002
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K021506
Shijiazhuang Great Vision Plastic Products Co., LT
General Hospital · 28d