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
1129–1152 of 1181
Cleared Mar 13, 1998
NITRILE EXAMINATION GLOVES - POWDER FREE
K980511
Influx Pacific Sdn. Bhd.
General Hospital · 31d
Cleared Feb 25, 1998
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
K974710
Sinochem Ningbo Latex Gloves Factory
General Hospital · 70d
Cleared Feb 09, 1998
POWDER-FREE NITRILE EXAMINATION GLOVES
K980150
Masju Sdn. Bhd.
General Hospital · 24d
Cleared Jan 30, 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K974886
Sri Johani Sdn. Bhd.
General Hospital · 31d
Cleared Jan 29, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K974887
Sri Johani Sdn. Bhd.
General Hospital · 30d
Cleared Jan 29, 1998
POWDERED NITRILE EXAMINATION GLOVES
K980149
Masju Sdn. Bhd.
General Hospital · 13d
Cleared Dec 18, 1997
DASH, VITAL GARD
K974114
Dash Medical Gloves Sdn Bhd
General Hospital · 48d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974183
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES
K974185
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
K974223
Derlin Company , Ltd.
General Hospital · 36d
Cleared Dec 17, 1997
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K973903
Sri Johani Sdn. Bhd.
General Hospital · 64d
Cleared Dec 17, 1997
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974182
Sri Johani Sdn. Bhd.
General Hospital · 41d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
K973058
Sri Johani Sdn. Bhd.
General Hospital · 81d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K973059
Sri Johani Sdn. Bhd.
General Hospital · 81d
Cleared Nov 06, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973551
Pwa Industries Sdn. Bhd.
General Hospital · 48d
Cleared Nov 05, 1997
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090
Shen Wei (Usa), Inc.
General Hospital · 154d
Cleared Oct 29, 1997
ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
K972757
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 98d
Cleared Oct 03, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169
Pwa Industries Sdn. Bhd.
General Hospital · 116d
Cleared Sep 26, 1997
NITRILE EXAMINATION GLOVES-PRE POWDERED
K970216
Influx Pacific Sdn. Bhd.
General Hospital · 253d
Cleared Sep 12, 1997
POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE
K972306
P.T. Irama Dinamika Latex
General Hospital · 85d
Cleared Sep 05, 1997
POWDER FREE SYNTHETIC EXAMINATION GLOVES
K971356
Arista Latindo Industrial Ltd. P.T
General Hospital · 147d
Cleared Aug 15, 1997
POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)
K972838
Absolute Synthetic Technologies Malaysia Sdn. Bhd.
General Hospital · 14d
Cleared Jul 29, 1997
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972177
Absolute Synthetic Technologies Malaysia Sdn. Bhd.
General Hospital · 49d
Cleared Jul 29, 1997
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972195
Absolute Synthetic Technologies Malaysia Sdn. Bhd.
General Hospital · 48d