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
649–672 of 1181
Cleared Aug 10, 2012
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
K121368
Matang Mfg. Sdn. Bhd.
General Hospital · 95d
Cleared Aug 03, 2012
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
K121192
Tekmedic (M) Sdn Bhd
General Hospital · 106d
Cleared Aug 03, 2012
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
K121526
Shandong Junchi Medical Products Co., Ltd.
General Hospital · 72d
Cleared Jul 19, 2012
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
K120970
Tangshan Zhonghong Pulin Plastic Co.,Ltd
General Hospital · 111d
Cleared Jul 12, 2012
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
K121529
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Jul 05, 2012
BLUE POWER FREE NITRILE EXAMINATION GLOVE
K121464
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Jul 03, 2012
UTB BLUE POWDER FREE NITRILE
K121506
Northstar Healthcare Holdings
General Hospital · 43d
Cleared Jun 08, 2012
LANO-E
K111718
Ug Global Resources Sdn. Bhd.
General Hospital · 354d
Cleared May 23, 2012
HIGH FIVE
K113440
Central Medicare Sdn Bhd
General Hospital · 184d
Cleared May 08, 2012
C2 MEDICAL GLOVES
K113639
Amercare, Inc.
General Hospital · 151d
Cleared May 02, 2012
RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
K112924
Riverstone Resources Sdn Bhd
General Hospital · 212d
Cleared May 02, 2012
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
K120184
Encompass Medical Supplies Inc Limited
General Hospital · 100d
Cleared Apr 19, 2012
PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
K111464
Dipped Products (Thailand), Ltd.
General Hospital · 329d
Cleared Apr 17, 2012
RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
K112928
Riverstone Resources Sdn Bhd
General Hospital · 197d
Cleared Mar 21, 2012
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
K112012
Ug Healthcare (Usa), Inc.
General Hospital · 252d
Cleared Mar 09, 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
K113423
Kimberly-Clark Corp.
General Hospital · 109d
Cleared Feb 06, 2012
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K113100
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 110d
Cleared Feb 02, 2012
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
K112976
Hartalega Snd. Bhd.
General Hospital · 119d
Cleared Jan 26, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K111134
Siem Aempemed Corp., Ltd.
General Hospital · 279d
Cleared Dec 01, 2011
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
K111248
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
K110979
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
K111772
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 119d
Cleared Oct 03, 2011
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K103675
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
K111589
Derma Care Plus Products, LLC
General Hospital · 77d