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
841–864 of 1181
Cleared Dec 06, 2004
MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
K042817
Ansell Healthcare Products, Inc.
General Hospital · 55d
Cleared Dec 01, 2004
POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
K041913
Pt. Medisafe Technologies
General Hospital · 139d
Cleared Sep 30, 2004
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
K042226
Syntex Healthcare Products Co., Ltd.
General Hospital · 44d
Cleared Sep 20, 2004
NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
K042378
Shijiazhuang Tillotson Rubber Products Co., Ltd.
General Hospital · 19d
Cleared Sep 16, 2004
CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
K042238
Seal Polymer Industries Bhd.
General Hospital · 29d
Cleared Aug 27, 2004
CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
K042101
Seal Polymer Industries Bhd.
General Hospital · 23d
Cleared Aug 20, 2004
POWDER-FREE NITRILE EXAMINATION GLOVES
K041276
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 100d
Cleared Aug 20, 2004
POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
K041848
Pt. Smartglove Indonesia
General Hospital · 43d
Cleared Jul 09, 2004
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391
Hartalega Sdn Bhd
General Hospital · 45d
Cleared Jul 08, 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841
Medline Industries, Inc.
General Hospital · 98d
Cleared Jun 03, 2004
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K040791
Pt. Smartglove Indonesia
General Hospital · 66d
Cleared Apr 22, 2004
MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
K040607
Pt. Medisafe Technologies
General Hospital · 45d
Cleared Mar 15, 2004
BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
K034052
Latexx Manufacturing Sdn.Bhd.
General Hospital · 76d
Cleared Mar 02, 2004
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K033887
Yty Industry (Manjung) Sdn Bhd
General Hospital · 78d
Cleared Feb 26, 2004
NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE
K033086
Pt. Medisafe Technologies
General Hospital · 150d
Cleared Feb 24, 2004
MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
K040176
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 29d
Cleared Feb 05, 2004
ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K033777
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Jan 08, 2004
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
K033683
Smart Glove Corp. Sdn Bhd
General Hospital · 45d
Cleared Oct 29, 2003
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024
Shen Wei (Usa), Inc.
General Hospital · 121d
Cleared Sep 23, 2003
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
K031944
Arista Latindo Industrial Ltd. P.T
General Hospital · 91d
Cleared Sep 08, 2003
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K032549
Matang Mfg. Sdn. Bhd.
General Hospital · 21d
Cleared Aug 19, 2003
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
K032010
Pt. Wrp Buana Multicorpora
General Hospital · 50d
Cleared Aug 19, 2003
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
K032011
Pt. Wrp Buana Multicorpora
General Hospital · 50d
Cleared Aug 19, 2003
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
K032077
Seal Polymer Industries Bhd.
General Hospital · 43d