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
553–576 of 1175
Cleared Jul 26, 2005
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778
Hartalega Sdn Bhd
General Hospital · 25d
Cleared Jun 07, 2005
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347
Kimberly-Clark Corp.
General Hospital · 14d
Cleared Mar 30, 2005
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
K050467
Shen Wei (Usa), Inc.
General Hospital · 35d
Cleared Mar 16, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214
Hartalega Sdn Bhd
General Hospital · 44d
Cleared Mar 11, 2005
NITRILE POWDERED EXAMINATION GLOVES (WHITE)
K050215
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Jan 13, 2005
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
K042879
Sgmp Co., Ltd.
General Hospital · 87d
Cleared Jul 09, 2004
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391
Hartalega Sdn Bhd
General Hospital · 45d
Cleared Jul 08, 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841
Medline Industries, Inc.
General Hospital · 98d
Cleared Oct 29, 2003
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024
Shen Wei (Usa), Inc.
General Hospital · 121d
Cleared Aug 01, 2003
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
K031625
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 66d
Cleared Aug 01, 2003
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
K031768
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 53d
Cleared Jun 26, 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
K031591
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 36d
Cleared Mar 03, 2003
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
K030335
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 31d
Cleared Jan 14, 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 26d
Cleared Dec 02, 2002
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
K023517
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 45d
Cleared Nov 18, 2002
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Oct 11, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765
Allegiance Healthcare Corp.
General Hospital · 52d
Cleared Oct 09, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Oct 03, 2002
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K022904
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 30d
Cleared Jun 06, 2002
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K021220
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Feb 14, 2002
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
K020317
Sgmp Co., Ltd.
General Hospital · 15d
Cleared Sep 26, 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961
Shen Wei (Usa), Inc.
General Hospital · 96d
Cleared Aug 16, 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 48d
Cleared Jul 09, 2001
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K011482
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 56d