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
865–888 of 1181
Cleared Aug 15, 2003
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
K031157
Qingdao Bestex Rubber & Plastic Products Co., Ltd.
General Hospital · 126d
Cleared Aug 08, 2003
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
K030529
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
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 Jul 25, 2003
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
K031580
Green Prospect Sdn Bhd
General Hospital · 66d
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 Jun 17, 2003
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G
K031384
Yty Industry (Manjung) Sdn Bhd
General Hospital · 47d
Cleared May 02, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
K030207
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 101d
Cleared Apr 04, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
K030245
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
K030386
Shamrock Manufacturing Company
General Hospital · 51d
Cleared Mar 25, 2003
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
K030284
Pt. Smartglove Indonesia
General Hospital · 57d
Cleared Mar 05, 2003
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
K030075
Best Manufacturing Company-Distribution Center
General Hospital · 56d
Cleared Mar 03, 2003
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
K030335
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 31d
Cleared Feb 27, 2003
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
K030406
Pt. Smartglove Indonesia
General Hospital · 20d
Cleared Feb 19, 2003
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
K022814
Pt. Smartglove Indonesia
General Hospital · 177d
Cleared Feb 13, 2003
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
K023072
Arista Latindo Industrial Ltd. P.T
General Hospital · 150d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE
K023978
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, PRE-POWDERED
K023979
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 14, 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 26d
Cleared Jan 10, 2003
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K024083
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 30d
Cleared Dec 18, 2002
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
K023702
Ningbo Tianshun Rubber Products Co., Ltd.
General Hospital · 47d
Cleared Dec 18, 2002
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
K024025
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 12d
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