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
Cleared
Sep 16, 2019
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
Kossan International Sdn Bhd
General Hospital
75d
Cleared
Sep 06, 2019
Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
Ever Global (Vietnam) Enterprise Corporation
General Hospital
199d
Cleared
Jul 30, 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
Platinum Glove Industries Sdn. Bhd.
General Hospital
362d
Cleared
Jul 26, 2019
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
Smart Glove Corporation Sdn. Bhd.
General Hospital
245d
Cleared
Jun 27, 2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
162d
Cleared
Jun 26, 2019
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O&M Halyard, Inc.
General Hospital
259d
Cleared
Jun 20, 2019
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
Gx Corporation Sdn Bhd
General Hospital
199d
Cleared
May 30, 2019
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital
279d
Cleared
May 28, 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Kossan International Sdn Bhd
General Hospital
81d
Cleared
May 10, 2019
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
Zibo Yahao Supplies Co., Ltd.
General Hospital
231d
Cleared
Apr 12, 2019
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
Shandong Hengya Packaging Printing Co.,Ltd
General Hospital
200d
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