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
1105–1128 of 1181
Cleared Aug 11, 1998
POWDERED NITRILE EXAMINATION GLOVES
K981879
Besglove Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Aug 11, 1998
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE
K982274
Asia Pacific Latex Sdn Bhd
General Hospital · 43d
Cleared Jul 28, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K981673
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 28, 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K981674
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 28, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981675
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 22, 1998
SUPERGLOVES POWDERED NITRILE
K980966
Supermax Sdn Bhd
General Hospital · 128d
Cleared Jun 22, 1998
NITRILON CORRECT-TOUCH
K981304
Ct Intl.
General Hospital · 73d
Cleared Jun 22, 1998
NITRILON CORRECT-TOUCH
K981333
Biopro (M) Sdn Bhd
General Hospital · 70d
Cleared Jun 05, 1998
POWDERED NITRILE EXAMINATION GLOVES
K981133
Servicom Services Sdn Bhd
General Hospital · 77d
Cleared Jun 01, 1998
PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
K981159
Latexx Partners Bhd.
General Hospital · 62d
Cleared May 18, 1998
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
K981349
Smart Glove Corp. Sdn Bhd
General Hospital · 38d
Cleared May 15, 1998
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
K981179
Lovytex Sdn Bhd
General Hospital · 44d
Cleared Apr 21, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981039
Sri Johani Sdn. Bhd.
General Hospital · 33d
Cleared Apr 14, 1998
AR SAFE NITRILE EXAMINATION GLOVES
K980589
Alliance Rubber Products Sdn. Bhd.
General Hospital · 56d
Cleared Apr 02, 1998
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)
K980729
Pt. Eka Wira Asia
General Hospital · 36d
Cleared Apr 02, 1998
NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)
K980807
Pt. Eka Wira Asia
General Hospital · 36d
Cleared Mar 25, 1998
NITRILE EXAM GLOVE, POWDER-FREE, BLUE
K980802
Tucker & Associates
General Hospital · 23d
Cleared Mar 16, 1998
NITRILE EXAM GLOVE, POWDER FREE
K980677
Ningbo Yujiang Plastic & Rubber Co. , Ltd.
General Hospital · 24d
Cleared Mar 13, 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907
Smart Glove Corp. Sdn Bhd
General Hospital · 72d
Cleared Mar 13, 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K980275
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K980280
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K980285
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE
K980419
Omnigrace (Thailand) , Ltd.
General Hospital · 38d
Cleared Mar 13, 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED
K980421
Omnigrace (Thailand) , Ltd.
General Hospital · 38d