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
Cleared
Aug 10, 2012
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
Matang Mfg. Sdn. Bhd.
General Hospital
95d
Cleared
Aug 03, 2012
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
Tekmedic (M) Sdn Bhd
General Hospital
106d
Cleared
Aug 03, 2012
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
Shandong Junchi Medical Products Co., Ltd.
General Hospital
72d
Cleared
Jul 19, 2012
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
Tangshan Zhonghong Pulin Plastic Co.,Ltd
General Hospital
111d
Cleared
Jul 12, 2012
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
Northstar Healthcare Holdings
General Hospital
49d
Cleared
Jul 05, 2012
BLUE POWER FREE NITRILE EXAMINATION GLOVE
Northstar Healthcare Holdings
General Hospital
49d
Cleared
Jul 03, 2012
UTB BLUE POWDER FREE NITRILE
Northstar Healthcare Holdings
General Hospital
43d
Cleared
Jun 08, 2012
LANO-E
Ug Global Resources Sdn. Bhd.
General Hospital
354d
Cleared
May 23, 2012
HIGH FIVE
Central Medicare Sdn Bhd
General Hospital
184d
Cleared
May 08, 2012
C2 MEDICAL GLOVES
Amercare, Inc.
General Hospital
151d
Cleared
May 02, 2012
RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
Riverstone Resources Sdn Bhd
General Hospital
212d
Cleared
May 02, 2012
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
Encompass Medical Supplies Inc Limited
General Hospital
100d
Cleared
Apr 19, 2012
PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
Dipped Products (Thailand), Ltd.
General Hospital
329d
Cleared
Apr 17, 2012
RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
Riverstone Resources Sdn Bhd
General Hospital
197d
Cleared
Mar 21, 2012
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
Ug Healthcare (Usa), Inc.
General Hospital
252d
Cleared
Mar 09, 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
Kimberly-Clark Corp.
General Hospital
109d
Cleared
Feb 06, 2012
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Maxter Glove Manufacturing Sdn Bhd
General Hospital
110d
Cleared
Feb 02, 2012
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
Hartalega Snd. Bhd.
General Hospital
119d
Cleared
Jan 26, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Siem Aempemed Corp., Ltd.
General Hospital
279d
Cleared
Dec 01, 2011
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
Yty Industry (Manjung) Sdn Bhd
General Hospital
212d
Cleared
Oct 20, 2011
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
Advanced Medical Products Sdn Bhd
General Hospital
196d
Cleared
Oct 20, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
Kossan Latex Industries(M)Sdn Bhd
General Hospital
119d
Cleared
Oct 03, 2011
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
Chienmax Vietnam Co., Ltd.
General Hospital
291d
Cleared
Aug 23, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
Derma Care Plus Products, LLC
General Hospital
77d