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
697–720 of 1181
Cleared Nov 19, 2010
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
K102880
Brightway Holdings Sdn. Bhd.
General Hospital · 50d
Cleared Nov 08, 2010
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES
K101943
Tangshan Jiteng Plastic Products Co., Ltd.
General Hospital · 119d
Cleared Nov 02, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
K102074
Gx Corporation Sdn Bhd
General Hospital · 99d
Cleared Oct 15, 2010
NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
K101351
Ascend Eagle, Inc.
General Hospital · 154d
Cleared Oct 08, 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K101594
Better Care Plastic Technology Cp., Ltd.
General Hospital · 122d
Cleared Oct 06, 2010
ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
K101760
Profit Point Manufacturing Sdn Bhd
General Hospital · 105d
Cleared Oct 04, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K102096
Syntex Healthcare Products Co., Ltd.
General Hospital · 69d
Cleared Sep 10, 2010
NUGARD NITILE GREY COLOR
K102230
Terang Nusa Sdn Bhd
General Hospital · 32d
Cleared Sep 08, 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646
Sgmp Co., Ltd.
General Hospital · 89d
Cleared Sep 08, 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032
Kimberly-Clark Corp.
General Hospital · 51d
Cleared Sep 07, 2010
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
K101630
Pt. Smartglove Indonesia
General Hospital · 89d
Cleared Aug 17, 2010
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
K100975
Jiangsu Sunshine Plastic Products, Co., Ltd.
General Hospital · 130d
Cleared Aug 06, 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K101595
Better Care Plastic Technology Cp., Ltd.
General Hospital · 59d
Cleared Jul 16, 2010
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K100603
Riverstone Resources Sdn Bhd
General Hospital · 135d
Cleared Jul 02, 2010
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
K100979
Jiangsu Sunshine Plastic Products, Co., Ltd.
General Hospital · 85d
Cleared Jul 01, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K101293
Pt. Smartglove Indonesia
General Hospital · 52d
Cleared Jun 29, 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
K093516
Summit Glove, Inc.
General Hospital · 228d
Cleared Jun 29, 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE
K093517
Summit Glove, Inc.
General Hospital · 228d
Cleared Jun 22, 2010
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092874
Quality Gallant Sdn. Bhd.
General Hospital · 277d
Cleared Jun 18, 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335
La Glove (M) Sdn. Bhd.
General Hospital · 235d
Cleared May 20, 2010
ROYAL GUARD
K092617
Shun Thai Rubber Gloves Industry Public Co., Ltd.
General Hospital · 267d
Cleared May 20, 2010
POWDER-FREE NITRILE GLOVES, BLACK
K100369
Hl Rubber Industries Sdn Bhd
General Hospital · 97d
Cleared Apr 15, 2010
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
K092472
Ascend Eagle, Inc.
General Hospital · 246d
Cleared Mar 24, 2010
MULTIPLE PRIVATE LABEL
K100162
Biogreen Yields Sdn.Bhd
General Hospital · 63d