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..

1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
577–600 of 1175
Cleared Jul 05, 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713
Kimberly-Clark Corp.
General Hospital · 31d
Cleared Apr 10, 2001
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
K010719
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 29d
Cleared Apr 03, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110
Shen Wei (Usa), Inc.
General Hospital · 81d
Cleared Mar 30, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K010097
Shen Wei (Usa), Inc.
General Hospital · 78d
Cleared Jan 26, 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 17d
Cleared Dec 04, 2000
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
K002391
Siam Sempermed Corp., Ltd.
General Hospital · 122d
Cleared Nov 29, 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
K002819
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 28, 2000
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
K002064
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 144d
Cleared Nov 22, 2000
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K001613
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 181d
Cleared Nov 22, 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353
Medline Industries, Inc.
General Hospital · 27d
Cleared May 03, 2000
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K991422
Shen Wei (Usa), Inc.
General Hospital · 376d
Cleared Apr 20, 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Feb 07, 2000
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K993876
Shen Wei (Usa), Inc.
General Hospital · 84d
Cleared Nov 23, 1999
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 50d
Cleared Nov 19, 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 46d
Cleared Jun 03, 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Mar 09, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Jan 25, 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
K984605
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Jan 08, 1999
NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
K984356
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 32d
Cleared Dec 11, 1998
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d