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
Cleared
Aug 24, 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
Hartalega NGC Sdn. Bhd.
General Hospital
97d
Cleared
Jun 09, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Hartalega Sdn Bhd
General Hospital
92d
Cleared
Apr 23, 2015
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
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)
Hartalega NGC Sdn. Bhd.
General Hospital
93d
Cleared
Feb 11, 2015
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
Siam Sempermed Corp., Ltd.
General Hospital
142d
Cleared
Dec 18, 2014
Nitrile Powder Free Examination Glove (Blue)
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
Hartalega Sdn Bhd
General Hospital
246d
Cleared
Aug 07, 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
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)
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)
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
Hartalega Sdn Bhd
General Hospital
156d
Cleared
Dec 13, 2013
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
Wrp Asia Pacific Sdn. Bhd.
General Hospital
127d
Cleared
Nov 07, 2013
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
Kimberly-Clark Corp.
General Hospital
139d
Cleared
Nov 07, 2013
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
Hartalega Sdn Bhd
General Hospital
129d
Cleared
Jul 05, 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
Hartalega Sdn Bhd
General Hospital
133d
Cleared
Dec 27, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
Siam Sempermed Corp., Ltd.
General Hospital
216d
Cleared
Sep 11, 2012
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
Shen Wei (Usa), Inc.
General Hospital
111d
Cleared
Sep 10, 2012
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Siam Sempermed Corp., Ltd.
General Hospital
35d
Cleared
Aug 17, 2012
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
Shen Wei (Usa), Inc.
General Hospital
147d
Cleared
Mar 09, 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
Kimberly-Clark Corp.
General Hospital
109d
Cleared
Aug 12, 2011
NITRILE POWDER FREE EXAMINATION GLOVES
Hartalega Sdn Bhd
General Hospital
147d
Cleared
Sep 08, 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
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
Kimberly-Clark Corp.
General Hospital
51d
Cleared
Feb 22, 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Medline Industries, Inc.
General Hospital
81d