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
1081–1104 of 1181
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990420
La Glove (M) Sdn. Bhd.
General Hospital · 47d
Cleared Mar 23, 1999
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
K990013
Yty Industry (Manjung) Sdn Bhd
General Hospital · 78d
Cleared Mar 09, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Mar 09, 1999
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K990453
Alliance Rubber Products Sdn. Bhd.
General Hospital · 25d
Cleared Feb 19, 1999
NITRILE POWDER FREE EXAMINATION GLOVES
K983334
Cranberry (M) Sdn. Bhd.
General Hospital · 149d
Cleared Feb 17, 1999
POWDERED NITRILE EXAMINATION GLOVES
K984615
Shiva Medicare , Ltd.
General Hospital · 50d
Cleared Feb 12, 1999
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
K984309
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 72d
Cleared Feb 09, 1999
NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE
K984311
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 69d
Cleared Feb 09, 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K984610
Shiva Medicare , Ltd.
General Hospital · 42d
Cleared Jan 25, 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
K984605
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Jan 21, 1999
NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
K983828
Sinetimed Latex Sdn Bhd
General Hospital · 83d
Cleared Jan 08, 1999
NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
K984356
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 32d
Cleared Dec 11, 1998
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d
Cleared Dec 11, 1998
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
K983730
Omnigrace , Ltd.
General Hospital · 50d
Cleared Dec 07, 1998
ARSOFT
K983146
Alliance Rubber Products Sdn. Bhd.
General Hospital · 90d
Cleared Dec 07, 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K983725
Omnigrace , Ltd.
General Hospital · 46d
Cleared Dec 04, 1998
NITRILE LATEX POWDERED EXAMINATION GLOVE
K983816
Top Glove Sdn. Bhd.
General Hospital · 36d
Cleared Dec 04, 1998
NITRILE LATEX POWDER FREE EXAMINATION GLOVE
K983825
Top Glove Sdn. Bhd.
General Hospital · 36d
Cleared Nov 30, 1998
NITRILE POWDER-FREE UNISEAL GLOVES
K982218
American Healthcare Products (M) Sdn Bhd
General Hospital · 159d
Cleared Nov 05, 1998
POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
K981064
P.T. Irama Dinamika Latex
General Hospital · 227d
Cleared Oct 29, 1998
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K982131
Ansell Edmont Industrial, Inc.
General Hospital · 134d
Cleared Sep 30, 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 78d
Cleared Aug 11, 1998
NITRILE POWDERFREE EXAMINATION GLOVES
K981877
Besglove Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Aug 11, 1998
POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981878
Besglove Medicare Sdn. Bhd.
General Hospital · 75d