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
1057–1080 of 1181
Cleared May 28, 1999
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
K991640
M.R.G. Industries Berhad
General Hospital · 16d
Cleared May 26, 1999
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K990963
Riverstone Resources Sdn Bhd
General Hospital · 64d
Cleared May 26, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K991493
Masju Sdn. Bhd.
General Hospital · 28d
Cleared May 21, 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
K990878
Brightway Holdings Sdn. Bhd.
General Hospital · 66d
Cleared May 21, 1999
LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)
K990882
La Glove (M) Sdn. Bhd.
General Hospital · 66d
Cleared May 17, 1999
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
K990840
Terang Nusa Sdn Bhd
General Hospital · 63d
Cleared May 17, 1999
NUGARD NITRIL NITRILE EXAMINATION GLOVE
K990841
Terang Nusa Sdn Bhd
General Hospital · 63d
Cleared May 13, 1999
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE
K990696
Omnigrace (Thailand) , Ltd.
General Hospital · 71d
Cleared May 13, 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
K990698
Omnigrace (Thailand) , Ltd.
General Hospital · 71d
Cleared May 05, 1999
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
K990701
Omnigrace (Thailand) , Ltd.
General Hospital · 63d
Cleared May 04, 1999
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
K984249
London International Group, Inc.
General Hospital · 155d
Cleared May 04, 1999
TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990575
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990577
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
K990695
Omnigrace (Thailand) , Ltd.
General Hospital · 62d
Cleared Apr 23, 1999
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
K990427
Alliance Rubber Products Sdn. Bhd.
General Hospital · 71d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
K990485
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
K990486
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 09, 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990541
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K990542
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 02, 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K990495
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
PREPOWDERED NITRILE EXAMINATION GLOVES
K990499
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Mar 29, 1999
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
K990267
Shanghai Palomar Mountain Industries, Inc.
General Hospital · 60d
Cleared Mar 29, 1999
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
K990299
Shanghai Palomar Mountain Industries, Inc.
General Hospital · 56d
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
K990415
La Glove (M) Sdn. Bhd.
General Hospital · 47d