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 Medline Industries, Inc., O&M Halyard, Inc. and Shen Wei (Usa), Inc..

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
457–480 of 1170
Cleared Apr 05, 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K183287
Kossan International Sdn Bhd
General Hospital · 130d
Cleared Mar 22, 2019
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
K182554
He Chuang Plastic & Rubber Co., Ltd.
General Hospital · 186d
Cleared Mar 11, 2019
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
K182241
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital · 203d
Cleared Jan 16, 2019
Powder Free Nitrile Patient Examination Gloves, Blue Color
K181106
Jiangsu Dongxin Medical Technology Co., Ltd.
General Hospital · 265d
Cleared Dec 21, 2018
Nitrile Glove Powder Free White
K183068
Haining Medical Products Co., Ltd.
General Hospital · 46d
Cleared Nov 30, 2018
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
K182600
Better Care Plastic Technology Co., Ltd.
General Hospital · 70d
Cleared Nov 20, 2018
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K181857
Kossan International Sdn Bhd
General Hospital · 132d
Cleared Nov 16, 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
K180645
Hartalega Sdn Bhd
General Hospital · 249d
Cleared Nov 15, 2018
Nitrile Glove Powder Free Black
K182528
Haining Medical Products Co., Ltd.
General Hospital · 62d
Cleared Nov 02, 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
K180786
Hartalega Sdn Bhd
General Hospital · 221d
Cleared Nov 02, 2018
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
K182096
Owens & Minor Halyard, Inc.
General Hospital · 91d
Cleared Oct 10, 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Sep 26, 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
K181066
Eco Medi Glove Sdn. Bhd.
General Hospital · 156d
Cleared Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509
Hartalega Sdn Bhd
General Hospital · 277d
Cleared Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644
Hartalega Sdn Bhd
General Hospital · 151d
Cleared Jul 05, 2018
Nitrile Patient Examination Powder Free Glove, Textured, Black
K161085
Multisafe Sdn. Bhd.
General Hospital · 808d
Cleared Jun 14, 2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
K180505
Hartalega Sdn Bhd
General Hospital · 108d
Cleared Jun 12, 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K180452
Riverstone Resources Sdn Bhd
General Hospital · 112d
Cleared Jun 11, 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422
Ever Global (Vietnam) Enterprise Corp
General Hospital · 392d
Cleared May 10, 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
K172867
Gmp Medicare Sdn Bhd (F25)
General Hospital · 232d
Cleared Apr 30, 2018
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
K180696
Medline Industries, Inc.
General Hospital · 45d
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