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
Cleared
Apr 05, 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Kossan International Sdn Bhd
General Hospital
130d
Cleared
Mar 22, 2019
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
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
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital
203d
Cleared
Jan 16, 2019
Powder Free Nitrile Patient Examination Gloves, Blue Color
Jiangsu Dongxin Medical Technology Co., Ltd.
General Hospital
265d
Cleared
Dec 21, 2018
Nitrile Glove Powder Free White
Haining Medical Products Co., Ltd.
General Hospital
46d
Cleared
Nov 30, 2018
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
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
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)
Hartalega Sdn Bhd
General Hospital
249d
Cleared
Nov 15, 2018
Nitrile Glove Powder Free Black
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
Hartalega Sdn Bhd
General Hospital
221d
Cleared
Nov 02, 2018
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
Owens & Minor Halyard, Inc.
General Hospital
91d
Cleared
Oct 10, 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc.
General Hospital
231d
Cleared
Oct 10, 2018
SBG Black Nitrile Powder Free Medical Examination Glove
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
Eco Medi Glove Sdn. Bhd.
General Hospital
156d
Cleared
Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
Hartalega Sdn Bhd
General Hospital
277d
Cleared
Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
Hartalega Sdn Bhd
General Hospital
151d
Cleared
Jul 05, 2018
Nitrile Patient Examination Powder Free Glove, Textured, Black
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)
Hartalega Sdn Bhd
General Hospital
108d
Cleared
Jun 12, 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
Riverstone Resources Sdn Bhd
General Hospital
112d
Cleared
Jun 11, 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
Ever Global (Vietnam) Enterprise Corp
General Hospital
392d
Cleared
May 10, 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
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)
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
Top Glove Sdn. Bhd.
General Hospital
213d
Cleared
Apr 13, 2018
mCare Powder-free Blue Nitrile Examination Gloves
Mercator Medical (Thailand), Ltd.
General Hospital
200d