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..

1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
481–504 of 1175
Cleared Apr 26, 2018
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
K172923
Top Glove Sdn. Bhd.
General Hospital · 213d
Cleared Apr 13, 2018
mCare Powder-free Blue Nitrile Examination Gloves
K172930
Mercator Medical (Thailand), Ltd.
General Hospital · 200d
Cleared Feb 22, 2018
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
K171171
Koon Seng Sdn Bhd
General Hospital · 307d
Cleared Feb 20, 2018
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
K173228
Jiangsu U-Med Rubber & Plastic Products Co., Ltd.
General Hospital · 139d
Cleared Dec 12, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
K173137
Hartalega Sdn Bhd
General Hospital · 74d
Cleared Nov 24, 2017
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678
Shen Wei (Usa), Inc.
General Hospital · 80d
Cleared Nov 06, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K172442
Hartalega NGC Sdn. Bhd.
General Hospital · 87d
Cleared Oct 12, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
K171874
Hartalega Sdn Bhd
General Hospital · 111d
Cleared Jul 25, 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312
Shen Wei (Usa), Inc.
General Hospital · 341d
Cleared Jun 30, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
K170794
Hartalega NGC Sdn. Bhd.
General Hospital · 106d
Cleared May 24, 2017
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
K170290
Shen Wei (Usa), Inc.
General Hospital · 114d
Cleared Mar 03, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162646
Hartalega NGC Sdn. Bhd.
General Hospital · 162d
Cleared Feb 27, 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K162982
Medline Industries, Inc.
General Hospital · 124d
Cleared Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491
Hartalega Sdn Bhd
General Hospital · 154d
Cleared Feb 06, 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE
K162923
Hartalega NGC Sdn. Bhd.
General Hospital · 111d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K162818
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
K162819
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Nov 17, 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
K161074
Shen Wei (Usa), Inc.
General Hospital · 213d
Cleared Oct 20, 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K161422
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 150d
Cleared Oct 19, 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K161473
Medline Industries, Inc.
General Hospital · 145d
Cleared Aug 04, 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K160560
Hartalega Sdn Bhd
General Hospital · 157d
Cleared Mar 31, 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997
Hartalega NGC Sdn. Bhd.
General Hospital · 255d
Cleared Oct 21, 2015
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
K151836
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Sep 18, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
K151684
Hartalega NGC Sdn. Bhd.
General Hospital · 88d