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
625–648 of 1181
Cleared Feb 22, 2013
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
K122727
Northstar Healthcare Holdings
General Hospital · 170d
Cleared Feb 21, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
K130038
Hl Rubber Industries Sdn Bhd
General Hospital · 45d
Cleared Feb 19, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
K123469
Wear Safe (Malaysia) Sdn Bhd - Facility II
General Hospital · 98d
Cleared Feb 11, 2013
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
K123116
Worldmed Manufacturing Sdn. Bhd.
General Hospital · 131d
Cleared Feb 08, 2013
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
K123488
Puyang Linshi Health Co., Ltd.
General Hospital · 87d
Cleared Jan 31, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696
Cardinal Health, Inc.
General Hospital · 149d
Cleared Jan 28, 2013
MULTIPLE NAME
K123760
Assurguard Sdn. Bhd.
General Hospital · 52d
Cleared Jan 18, 2013
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
K121592
Tekmedic (M) Sdn Bhd
General Hospital · 232d
Cleared Jan 18, 2013
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
K123328
Nitrilist Gloves Manufacturing Sdn Bhd
General Hospital · 88d
Cleared Jan 17, 2013
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
K122408
Hongye Plastic Products Co., Ltd.
General Hospital · 162d
Cleared Dec 27, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549
Siam Sempermed Corp., Ltd.
General Hospital · 216d
Cleared Dec 10, 2012
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
K122874
Nitrilist Gloves Manufacturing Sdn Bhd
General Hospital · 82d
Cleared Nov 30, 2012
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K122999
Top Glove Sdn. Bhd.
General Hospital · 64d
Cleared Nov 16, 2012
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
K120066
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 312d
Cleared Nov 06, 2012
BLUE POWDERED NITRILE EXAMINATION GLOVE
K122998
Northstar Healthcare Holdings
General Hospital · 40d
Cleared Oct 17, 2012
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
K122131
Matang Mfg. Sdn. Bhd.
General Hospital · 91d
Cleared Oct 16, 2012
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K121992
Xinwei (Shandong) Plastic and Rubber Products Co.,
General Hospital · 102d
Cleared Oct 16, 2012
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
K122465
Industrial Clothings, Ltd.
General Hospital · 64d
Cleared Oct 04, 2012
ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
K120110
Profit Point Manufacturing Sdn Bhd
General Hospital · 265d
Cleared Sep 11, 2012
POWDER FREE BLACK NITRILE EXAMINATION GLOVES
K113393
Tg Medical Sdn. Bhd.
General Hospital · 299d
Cleared Sep 11, 2012
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K121528
Shen Wei (Usa), Inc.
General Hospital · 111d
Cleared Sep 10, 2012
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
K121947
Northstar Healthcare Holdings
General Hospital · 69d
Cleared Sep 10, 2012
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K122363
Siam Sempermed Corp., Ltd.
General Hospital · 35d
Cleared Aug 17, 2012
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
K120890
Shen Wei (Usa), Inc.
General Hospital · 147d