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
745–768 of 1181
Cleared Mar 11, 2009
BIOCLEAN CHEMO SHIELD
K081970
Nitritex (M) Sdn. Bhd.
General Hospital · 244d
Cleared Mar 06, 2009
BLACK NITRILE EXAMINATION GLOVES
K083908
Innovative Gloves Co;, Ltd.
General Hospital · 66d
Cleared Mar 05, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755
Siam Sempermed Corp., Ltd.
General Hospital · 78d
Cleared Feb 10, 2009
N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
K082428
Best Glove, Inc.
General Hospital · 172d
Cleared Feb 10, 2009
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
K083624
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital · 64d
Cleared Jan 30, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
K083717
Gx Corporation Sdn Bhd
General Hospital · 46d
Cleared Jan 15, 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
K081911
Siam Sempermed Corp., Ltd.
General Hospital · 196d
Cleared Jan 07, 2009
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
K082598
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital · 121d
Cleared Dec 11, 2008
BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
K081972
Nitritex (M) Sdn. Bhd.
General Hospital · 154d
Cleared Dec 09, 2008
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
K082302
Pt. Medisafe Technologies
General Hospital · 119d
Cleared Dec 03, 2008
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
K081592
Quality Gallant Sdn. Bhd.
General Hospital · 180d
Cleared Nov 21, 2008
N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT
K082125
Best Glove, Inc.
General Hospital · 115d
Cleared Nov 10, 2008
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
K082457
Ansell Healthcare Products, Inc.
General Hospital · 76d
Cleared Oct 17, 2008
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594
Medline Industries, Inc.
General Hospital · 133d
Cleared Oct 17, 2008
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K082370
Smart Glove Corp. Sdn Bhd
General Hospital · 60d
Cleared Sep 12, 2008
DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
K081569
Dynarex Corporation
General Hospital · 100d
Cleared Aug 11, 2008
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)
K081315
Gx Corporation Sdn Bhd
General Hospital · 94d
Cleared Jul 30, 2008
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K081466
Smart Glove Corp. Sdn Bhd
General Hospital · 64d
Cleared Jul 09, 2008
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
K081260
Kimberly-Clark Corp.
General Hospital · 68d
Cleared Jun 30, 2008
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
K081027
Kimberly-Clark Corp.
General Hospital · 81d
Cleared Jun 19, 2008
MICRO-TOUCH NITRAFREE
K080536
Ansell Healthcare Products, LLC
General Hospital · 113d
Cleared May 23, 2008
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
K080937
Gx Corporation Sdn Bhd
General Hospital · 51d
Cleared May 14, 2008
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
K080165
Platinum Glove Industries Sdn. Bhd.
General Hospital · 112d
Cleared Apr 30, 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
K080520
Siam Sempermed Corp., Ltd.
General Hospital · 65d