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
769–792 of 1181
Cleared Mar 27, 2008
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
K072400
Sgmp Co., Ltd.
General Hospital · 213d
Cleared Mar 05, 2008
VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
K080066
Gx Corporation Sdn Bhd
General Hospital · 55d
Cleared Oct 04, 2007
CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
K071740
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 99d
Cleared Sep 14, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
K071170
Smart Glove Corp. Sdn Bhd
General Hospital · 140d
Cleared Sep 06, 2007
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
K071910
Hartalega Sdn Bhd
General Hospital · 57d
Cleared Aug 30, 2007
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
K071072
Shanghai China Star Corp
General Hospital · 136d
Cleared Aug 07, 2007
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
K071207
High Momentum Sdn Bhd
General Hospital · 98d
Cleared Jul 30, 2007
MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES
K071208
High Momentum Sdn Bhd
General Hospital · 90d
Cleared Jul 24, 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)
K071119
Gx Corporation Sdn Bhd
General Hospital · 95d
Cleared Jun 15, 2007
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
K070639
Siam Sempermed Corp., Ltd.
General Hospital · 100d
Cleared May 30, 2007
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE)
K070862
Purtech Cleanroom Products Co., Ltd.
General Hospital · 63d
Cleared May 15, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K070861
Hong Xin Rubber Products Co., Ltd.
General Hospital · 48d
Cleared Apr 19, 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
K061756
Shen Wei (Usa), Inc.
General Hospital · 302d
Cleared Apr 09, 2007
POWERED NITRILE BLUE EXAMINATION GLOVES
K061505
Liwe Trading
General Hospital · 312d
Cleared Mar 26, 2007
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K070404
Tangshan Luxiong Plastic Products Co., Ltd.
General Hospital · 42d
Cleared Mar 23, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K070097
Gx Corporation Sdn Bhd
General Hospital · 72d
Cleared Mar 20, 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919
Shen Wei (Usa), Inc.
General Hospital · 173d
Cleared Mar 20, 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K063627
Smart Glove Corp. Sdn Bhd
General Hospital · 104d
Cleared Mar 19, 2007
POWDER FREE NITRILE BLUE EXAMINATION GLOVE
K061504
Liwe Trading
General Hospital · 291d
Cleared Mar 14, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
K070096
Gx Corporation Sdn Bhd
General Hospital · 63d
Cleared Feb 23, 2007
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
K063777
Bright Element Sdn Bhd
General Hospital · 63d
Cleared Feb 08, 2007
POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
K063522
Hl Rubber Industries Sdn Bhd
General Hospital · 78d
Cleared Jan 23, 2007
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
K063524
Hl Rubber Industries Sdn Bhd
General Hospital · 62d
Cleared Nov 17, 2006
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
K063046
Hartalega Sdn Bhd
General Hospital · 44d