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
673–696 of 1181
Cleared Aug 19, 2011
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
K103734
Central Medicare Sdn Bhd
General Hospital · 240d
Cleared Aug 12, 2011
NITRILE POWDER FREE EXAMINATION GLOVES
K110758
Hartalega Sdn Bhd
General Hospital · 147d
Cleared Aug 12, 2011
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
K111300
Pt Mahakarya Inti Buana
General Hospital · 95d
Cleared Jul 15, 2011
POWDER FREE NITRILE EXAMINATION GLOVES
K111328
Gx Corporation Sdn Bhd
General Hospital · 65d
Cleared Jul 14, 2011
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
K110960
Koon Seng Sdn Bhd
General Hospital · 100d
Cleared Jul 13, 2011
POWDER FREE NITRILE EXAMINATION GLOVES
K110418
W.A. Rubbermate Co., Ltd.
General Hospital · 149d
Cleared Jun 15, 2011
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
K110297
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 134d
Cleared Jun 10, 2011
POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K110247
Jiangsu Dongling Plastic & Rubber Co., Ltd.
General Hospital · 133d
Cleared Jun 10, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
K110248
Jiangsu Dongling Plastic & Rubber Co., Ltd.
General Hospital · 133d
Cleared Jun 06, 2011
BLUE POWDERFREE NITRILE EXAMINATION GLOVE
K102623
Pt. Medisafe Technologies
General Hospital · 266d
Cleared May 23, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110155
Tangshan Xiangrui Plastic Products Co., Ltd.
General Hospital · 124d
Cleared May 13, 2011
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
K110102
Preventive Care, Inc.
General Hospital · 120d
Cleared May 13, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110146
Tangshan Kaiyue Glove Co., Ltd.
General Hospital · 115d
Cleared Apr 21, 2011
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
K103770
Syntex Healthcare Products Co., Ltd.
General Hospital · 115d
Cleared Apr 15, 2011
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K110921
Cardinal Health, Inc.
General Hospital · 14d
Cleared Apr 04, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110185
Tangshan Baojie Glove Co., Ltd.
General Hospital · 73d
Cleared Mar 31, 2011
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
K103670
Innovative Gloves Co;, Ltd.
General Hospital · 105d
Cleared Mar 23, 2011
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
K103661
Rubbercare Protection Products Sdn Bhd
General Hospital · 97d
Cleared Mar 17, 2011
PATIENT EXAMINATION GLOVES
K102846
Thai Hua Holding Co., Ltd.
General Hospital · 169d
Cleared Mar 03, 2011
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
K101820
Yty Industry (Manjung) Sdn Bhd
General Hospital · 246d
Cleared Feb 25, 2011
MULTIPLE NAME
K103337
Ideal Quality Sdn., Bhd.
General Hospital · 102d
Cleared Dec 20, 2010
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
K101870
Sunmax Vietnam Co., Ltd.
General Hospital · 167d
Cleared Dec 16, 2010
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K103249
Cardinal Health, Inc.
General Hospital · 43d
Cleared Nov 22, 2010
POWDERFREE BLACK NITRILE EXAMINATION GLOVES
K102620
Pt. Medisafe Technologies
General Hospital · 70d