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..

1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
505–528 of 1175
Cleared Aug 24, 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
K151343
Hartalega NGC Sdn. Bhd.
General Hospital · 97d
Cleared Jun 09, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K150593
Hartalega Sdn Bhd
General Hospital · 92d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
K150103
Hartalega Sdn Bhd
General Hospital · 93d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
K150110
Hartalega NGC Sdn. Bhd.
General Hospital · 93d
Cleared Feb 11, 2015
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
K142685
Siam Sempermed Corp., Ltd.
General Hospital · 142d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove (Blue)
K142588
Hartalega Sdn Bhd
General Hospital · 94d
Cleared Sep 12, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
K140050
Hartalega Sdn Bhd
General Hospital · 246d
Cleared Aug 07, 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 294d
Cleared Jul 24, 2014
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
K140890
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Jun 20, 2014
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
K140610
Hartalega NGC Sdn. Bhd.
General Hospital · 102d
Cleared May 28, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
K133956
Hartalega Sdn Bhd
General Hospital · 156d
Cleared Dec 13, 2013
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K132484
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 127d
Cleared Nov 07, 2013
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
K131841
Kimberly-Clark Corp.
General Hospital · 139d
Cleared Nov 07, 2013
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
K132006
Hartalega Sdn Bhd
General Hospital · 129d
Cleared Jul 05, 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473
Hartalega Sdn Bhd
General Hospital · 133d
Cleared Dec 27, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549
Siam Sempermed Corp., Ltd.
General Hospital · 216d
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
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
Cleared Mar 09, 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
K113423
Kimberly-Clark Corp.
General Hospital · 109d
Cleared Aug 12, 2011
NITRILE POWDER FREE EXAMINATION GLOVES
K110758
Hartalega Sdn Bhd
General Hospital · 147d
Cleared Sep 08, 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646
Sgmp Co., Ltd.
General Hospital · 89d
Cleared Sep 08, 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032
Kimberly-Clark Corp.
General Hospital · 51d
Cleared Feb 22, 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726
Medline Industries, Inc.
General Hospital · 81d