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
793–816 of 1181
Cleared Oct 27, 2006
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
K062778
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 39d
Cleared Oct 05, 2006
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE
K062138
Molnlycke Health Care, Inc.
General Hospital · 71d
Cleared Sep 06, 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067
Shen Wei (Usa), Inc.
General Hospital · 47d
Cleared Jul 25, 2006
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
K061724
Smart Glove Corp. Sdn Bhd
General Hospital · 36d
Cleared Jul 17, 2006
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
K061553
Yty Industry (Manjung) Sdn Bhd
General Hospital · 42d
Cleared Jun 14, 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583
Hartalega Sdn Bhd
General Hospital · 267d
Cleared Jun 09, 2006
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
K060402
Brightway Holdings Sdn. Bhd.
General Hospital · 114d
Cleared May 25, 2006
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
K060726
Smart Glove Corp. Sdn Bhd
General Hospital · 69d
Cleared May 24, 2006
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
K061074
Bright Element Sdn Bhd
General Hospital · 37d
Cleared May 23, 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192
Ethicon Endo-Surgery, LLC
General Hospital · 25d
Cleared May 17, 2006
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
K060724
Smart Glove Corp. Sdn Bhd
General Hospital · 61d
Cleared May 01, 2006
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
K060073
Shen Wei (Usa), Inc.
General Hospital · 112d
Cleared May 01, 2006
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
K060771
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 40d
Cleared Apr 28, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K060147
Hongye Plastic Products Co., Ltd.
General Hospital · 99d
Cleared Apr 27, 2006
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
K060753
Siam Sempermed Corp., Ltd.
General Hospital · 37d
Cleared Apr 24, 2006
SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44
K060733
Barriermed, Inc.
General Hospital · 35d
Cleared Mar 30, 2006
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
K053366
Pt Mahakarya Inti Buana
General Hospital · 115d
Cleared Feb 13, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K053657
Pt Mahakarya Inti Buana
General Hospital · 70d
Cleared Jan 19, 2006
NITRILE BLUE POWDERED EXAMINATION GLOVES
K052955
Great Glove Sdn Bhd
General Hospital · 90d
Cleared Dec 21, 2005
NITRILE BLUE POWDER FREE EXAMINATION GLOVE
K052956
Great Glove Sdn Bhd
General Hospital · 61d
Cleared Nov 30, 2005
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
K052892
Barriermed Glove Co.
General Hospital · 47d
Cleared Nov 18, 2005
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
K052502
Yty Industry (Manjung) Sdn Bhd
General Hospital · 66d
Cleared Nov 08, 2005
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
K052877
Syntex Healthcare Products Co., Ltd.
General Hospital · 27d
Cleared Oct 31, 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890
Siam Sempermed Corp., Ltd.
General Hospital · 18d