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
577–600 of 1181
Cleared Jun 12, 2015
Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS
K150414
Industrial Clothings (Pvt), Ltd.
General Hospital · 114d
Cleared Jun 09, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K150593
Hartalega Sdn Bhd
General Hospital · 92d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
K150103
Hartalega Sdn Bhd
General Hospital · 93d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
K150110
Hartalega NGC Sdn. Bhd.
General Hospital · 93d
Cleared Feb 12, 2015
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla
K143055
Yty Industry (Manjung) Sdn Bhd
General Hospital · 112d
Cleared Feb 12, 2015
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K143131
Kossan International Sdn Bhd
General Hospital · 104d
Cleared Feb 11, 2015
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
K142685
Siam Sempermed Corp., Ltd.
General Hospital · 142d
Cleared Feb 09, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
K142858
Careplus (M) Sdn Bhd
General Hospital · 131d
Cleared Jan 22, 2015
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)
K143247
Central Medicare Sdn Bhd
General Hospital · 71d
Cleared Jan 16, 2015
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
K142283
Yty Industry (Manjung) Sdn Bhd
General Hospital · 154d
Cleared Jan 16, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
K142862
Careplus (M) Sdn Bhd
General Hospital · 107d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove (Blue)
K142588
Hartalega Sdn Bhd
General Hospital · 94d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
K142805
Hartalega Sdb. Bhd.
General Hospital · 80d
Cleared Dec 12, 2014
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141303
Zhida Glove Co., Ltd.
General Hospital · 207d
Cleared Dec 12, 2014
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141304
Yongxin Healthcare Co., Ltd.
General Hospital · 207d
Cleared Dec 03, 2014
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141279
Wanghui Glove Co., Ltd.
General Hospital · 201d
Cleared Dec 03, 2014
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR
K141287
Huikang Glove Co., Ltd.
General Hospital · 201d
Cleared Oct 17, 2014
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141579
Eco Medi Glove Sdn. Bhd.
General Hospital · 126d
Cleared Oct 07, 2014
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K141510
Eco Medi Glove Sdn. Bhd.
General Hospital · 120d
Cleared Oct 07, 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K141623
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Sep 12, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
K140050
Hartalega Sdn Bhd
General Hospital · 246d
Cleared Sep 03, 2014
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K140418
Wrp Rubber Products Sdn Bhd
General Hospital · 197d
Cleared Sep 03, 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141590
Eco Medi Glove Sdn. Bhd.
General Hospital · 82d
Cleared Aug 26, 2014
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
K141021
Hl Rubber Industries Sdn Bhd
General Hospital · 127d