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..

1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
601–624 of 1175
Cleared Sep 30, 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 78d
Cleared Nov 05, 1997
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090
Shen Wei (Usa), Inc.
General Hospital · 154d
Cleared Feb 10, 1997
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804
Hartalega Sdn Bhd
General Hospital · 140d
Cleared Feb 10, 1997
NITRILE POWDER-FREE EXAMINATION GLOVES
K964628
Shen Wei (Usa), Inc.
General Hospital · 83d
Cleared Feb 07, 1997
PATIENT EXAMINATION GLOVES
K964148
Hartalega Sdn Bhd
General Hospital · 114d
Cleared Aug 14, 1996
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES
K962461
Shen Wei (Usa), Inc.
General Hospital · 50d
Cleared Dec 15, 1995
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
K951938
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 234d
Cleared Dec 15, 1995
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
K952051
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 228d
Cleared Dec 15, 1995
SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES
K952154
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 221d
Cleared Dec 11, 1995
SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES
K952155
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 217d
Cleared Oct 30, 1995
SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES)
K951921
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 189d
Cleared Oct 30, 1995
SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD)
K952052
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 182d
Cleared May 22, 1984
DISPOSABLE POLY GLOVES
K841676
Abco Dealers, Inc.
General Hospital · 29d