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
601–624 of 1181
Cleared Aug 08, 2014
BLUE NITRILE POWDER FREE EXAM GLOVES
K133325
Shandong Xinshi Medical Products Co., Ltd.
General Hospital · 283d
Cleared Aug 07, 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168
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)
K140890
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Jul 18, 2014
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
K133699
Pt. Smartglove Indonesia
General Hospital · 227d
Cleared Jul 11, 2014
EXAMINATION GLOVES
K140316
Hl Rubber Industries Sdn Bhd
General Hospital · 151d
Cleared Jul 08, 2014
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K140816
Better Care Plastic Technology Co., Ltd.
General Hospital · 98d
Cleared Jul 03, 2014
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
K133689
Pt. Medisafe Technologies
General Hospital · 213d
Cleared Jun 30, 2014
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE
K132354
Advanced Health Products, Lot 60 & 61
General Hospital · 336d
Cleared Jun 23, 2014
RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K133193
Riverstone Resources Sdn Bhd
General Hospital · 249d
Cleared Jun 20, 2014
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
K140610
Hartalega NGC Sdn. Bhd.
General Hospital · 102d
Cleared Jun 02, 2014
POWDER FREE POLYETHYLENE EXAMINATION GLOVES
K133478
Shijiazhuang Hongzan Plastic Technology Co.,Ltd
General Hospital · 202d
Cleared May 30, 2014
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
K133123
Yty Industry (Manjung) Sdn Bhd
General Hospital · 242d
Cleared May 28, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
K133956
Hartalega Sdn Bhd
General Hospital · 156d
Cleared Apr 08, 2014
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K133949
Top Calibre Sdn Bhd
General Hospital · 106d
Cleared Dec 13, 2013
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K132484
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 127d
Cleared Nov 07, 2013
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
K131841
Kimberly-Clark Corp.
General Hospital · 139d
Cleared Nov 07, 2013
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
K132006
Hartalega Sdn Bhd
General Hospital · 129d
Cleared Sep 25, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K131440
Hebei Hongsen Plastics Technology Co, Ltd.
General Hospital · 128d
Cleared Aug 08, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN
K130846
Industrial Clothings, Ltd.
General Hospital · 134d
Cleared Jul 05, 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473
Hartalega Sdn Bhd
General Hospital · 133d
Cleared Apr 12, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
K122464
Industrial Clothings, Ltd.
General Hospital · 242d
Cleared Apr 05, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
K122453
Industrial Clothings, Ltd.
General Hospital · 235d
Cleared Mar 01, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
K123749
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 85d
Cleared Feb 28, 2013
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K123869
Dehai (Shandong) Medical Gloves, Co., Ltd.
General Hospital · 73d