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
Aug 15, 2003
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
Qingdao Bestex Rubber & Plastic Products Co., Ltd.
General Hospital
126d
Cleared
Aug 08, 2003
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
Jda (Tianjin) Plastic Rubber Co., Ltd.
General Hospital
170d
Cleared
Aug 01, 2003
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
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
Perusahaan Getah Asas Sdn. Bhd.
General Hospital
53d
Cleared
Jul 25, 2003
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
Green Prospect Sdn Bhd
General Hospital
66d
Cleared
Jun 26, 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
Perusahaan Getah Asas Sdn. Bhd.
General Hospital
36d
Cleared
Jun 17, 2003
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G
Yty Industry (Manjung) Sdn Bhd
General Hospital
47d
Cleared
May 02, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
Shanghai Motex Healthcare Co., Ltd.
General Hospital
101d
Cleared
Apr 04, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
Arista Latindo Industrial Ltd. P.T
General Hospital
70d
Cleared
Mar 28, 2003
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
Shamrock Manufacturing Company
General Hospital
51d
Cleared
Mar 25, 2003
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
Pt. Smartglove Indonesia
General Hospital
57d
Cleared
Mar 05, 2003
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
Best Manufacturing Company-Distribution Center
General Hospital
56d
Cleared
Mar 03, 2003
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
Perusahaan Getah Asas Sdn. Bhd.
General Hospital
31d
Cleared
Feb 27, 2003
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
Pt. Smartglove Indonesia
General Hospital
20d
Cleared
Feb 19, 2003
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
Pt. Smartglove Indonesia
General Hospital
177d
Cleared
Feb 13, 2003
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
Arista Latindo Industrial Ltd. P.T
General Hospital
150d
Cleared
Jan 24, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE
Starmatrix Sdn Bhd
General Hospital
53d
Cleared
Jan 24, 2003
NITRILE EXAMINATION GLOVES, PRE-POWDERED
Starmatrix Sdn Bhd
General Hospital
53d
Cleared
Jan 14, 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
Perusahaan Getah Asas Sdn. Bhd.
General Hospital
26d
Cleared
Jan 10, 2003
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Supermax Glove Manufacturing Sdn Bhd
General Hospital
30d
Cleared
Dec 18, 2002
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
Ningbo Tianshun Rubber Products Co., Ltd.
General Hospital
47d
Cleared
Dec 18, 2002
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
Kossan Latex Industries(M)Sdn Bhd
General Hospital
12d
Cleared
Dec 02, 2002
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
Wrp Asia Pacific Sdn. Bhd.
General Hospital
45d
Cleared
Nov 18, 2002
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
Hartalega Sdn Bhd
General Hospital
98d