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
817–840 of 1181
Cleared Sep 15, 2005
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K052382
Pt.Shamrock Manufacturing Corp.
General Hospital · 16d
Cleared Aug 12, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
K051777
Hartalega Sdn Bhd
General Hospital · 42d
Cleared Aug 03, 2005
POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K051378
Medline
General Hospital · 69d
Cleared Jul 26, 2005
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778
Hartalega Sdn Bhd
General Hospital · 25d
Cleared Jul 22, 2005
NITRILE EXAMINATION GLOVES, POWDER FREE
K051333
Shun Thai Rubber Gloves Industry Co., Ltd.
General Hospital · 60d
Cleared Jul 22, 2005
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
K051662
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Jul 12, 2005
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
K050968
Pt. Medisafe Technologies
General Hospital · 85d
Cleared Jul 07, 2005
POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
K051372
Platinum Glove Industries Sdn. Bhd.
General Hospital · 42d
Cleared Jun 20, 2005
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR
K051317
Platinum Glove Industries Sdn. Bhd.
General Hospital · 31d
Cleared Jun 17, 2005
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
K051318
Platinum Glove Industries Sdn. Bhd.
General Hospital · 28d
Cleared Jun 07, 2005
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347
Kimberly-Clark Corp.
General Hospital · 14d
Cleared May 25, 2005
FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)
K043149
Firstline, LLC
General Hospital · 191d
Cleared May 19, 2005
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)
K050528
Spi Gloves Sdn. Bhd.
General Hospital · 78d
Cleared Apr 18, 2005
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
K050122
Smart Glove Corp. Sdn Bhd
General Hospital · 89d
Cleared Apr 08, 2005
LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
K050765
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 15d
Cleared Apr 07, 2005
POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
K050598
Smart Glove Corp. Sdn Bhd
General Hospital · 29d
Cleared Mar 30, 2005
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
K050467
Shen Wei (Usa), Inc.
General Hospital · 35d
Cleared Mar 18, 2005
POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)
K050531
Spi Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Mar 16, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214
Hartalega Sdn Bhd
General Hospital · 44d
Cleared Mar 16, 2005
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)
K050530
Spi Gloves Sdn. Bhd.
General Hospital · 14d
Cleared Mar 11, 2005
NITRILE POWDERED EXAMINATION GLOVES (WHITE)
K050215
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Jan 18, 2005
PANTHERA N POWDER FREE BLACK NITRILE GLOVES
K042898
Glovco (M) Sdn. Bhd.
General Hospital · 90d
Cleared Jan 13, 2005
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
K042879
Sgmp Co., Ltd.
General Hospital · 87d
Cleared Dec 16, 2004
FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
K042239
Pt. Mandiri Inti Buana
General Hospital · 120d