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
Cleared
Oct 27, 2006
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
Wear Safe Malaysia Sdn. Bhd.
General Hospital
39d
Cleared
Oct 05, 2006
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE
Molnlycke Health Care, Inc.
General Hospital
71d
Cleared
Sep 06, 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
Shen Wei (Usa), Inc.
General Hospital
47d
Cleared
Jul 25, 2006
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
Smart Glove Corp. Sdn Bhd
General Hospital
36d
Cleared
Jul 17, 2006
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
Yty Industry (Manjung) Sdn Bhd
General Hospital
42d
Cleared
Jun 14, 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
Hartalega Sdn Bhd
General Hospital
267d
Cleared
Jun 09, 2006
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
Brightway Holdings Sdn. Bhd.
General Hospital
114d
Cleared
May 25, 2006
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
Smart Glove Corp. Sdn Bhd
General Hospital
69d
Cleared
May 24, 2006
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
Bright Element Sdn Bhd
General Hospital
37d
Cleared
May 23, 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
Ethicon Endo-Surgery, LLC
General Hospital
25d
Cleared
May 17, 2006
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
Smart Glove Corp. Sdn Bhd
General Hospital
61d
Cleared
May 01, 2006
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
Shen Wei (Usa), Inc.
General Hospital
112d
Cleared
May 01, 2006
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
Kossan Latex Industries(M)Sdn Bhd
General Hospital
40d
Cleared
Apr 28, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
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)
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
Barriermed, Inc.
General Hospital
35d
Cleared
Mar 30, 2006
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
Pt Mahakarya Inti Buana
General Hospital
115d
Cleared
Feb 13, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
Pt Mahakarya Inti Buana
General Hospital
70d
Cleared
Jan 19, 2006
NITRILE BLUE POWDERED EXAMINATION GLOVES
Great Glove Sdn Bhd
General Hospital
90d
Cleared
Dec 21, 2005
NITRILE BLUE POWDER FREE EXAMINATION GLOVE
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
Barriermed Glove Co.
General Hospital
47d
Cleared
Nov 18, 2005
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
Yty Industry (Manjung) Sdn Bhd
General Hospital
66d
Cleared
Nov 08, 2005
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
Syntex Healthcare Products Co., Ltd.
General Hospital
27d
Cleared
Oct 31, 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
Siam Sempermed Corp., Ltd.
General Hospital
18d