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
Nov 28, 2023
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
Dehai (Shandong) Medical Gloves, Co., Ltd.
General Hospital
123d
Cleared
Nov 21, 2023
Medical Nitrile Examination Gloves
Jiangsu Complete Sincerity Medical New Materials Co., Ltd.
General Hospital
88d
Cleared
Nov 17, 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
Wrp Asia Pacific Sdn. Bhd.
General Hospital
87d
Cleared
Nov 14, 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Kossan International Sdn Bhd
General Hospital
91d
Cleared
Nov 03, 2023
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co., Ltd.
General Hospital
95d
Cleared
Oct 30, 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
Zhonghong Pulin Medical Products Co., Ltd.
General Hospital
202d
Cleared
Oct 26, 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Zhonghong Pulin Medical Products Co., Ltd.
General Hospital
230d
Cleared
Oct 20, 2023
Nitrile Examination Gloves, Dual Color Black-Blue
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital
58d
Cleared
Oct 11, 2023
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
Better Care Plastic Technology Co., Ltd.
General Hospital
91d
Cleared
Oct 06, 2023
Patient Examination Gloves
3A Glove Sdn. Bhd.
General Hospital
199d
Cleared
Oct 04, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
Better Care Plastic Technology Co., Ltd.
General Hospital
126d
Cleared
Oct 02, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
Central Medicare Sdn Bhd
General Hospital
203d
Cleared
Oct 02, 2023
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
Isikel Manufacturing, LLC
General Hospital
83d
Cleared
Sep 29, 2023
Chemotherapy Gloves
3A Glove Sdn. Bhd.
General Hospital
185d
Cleared
Sep 21, 2023
Powder-Free Nitrile Examination Gloves
Global Protection Corp.
General Hospital
339d
Cleared
Sep 08, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Syntex Healthcare Products Co., Ltd.
General Hospital
95d
Cleared
Aug 31, 2023
Powder Free Nitrile Examination Gloves (Black)
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital
24d
Cleared
Aug 28, 2023
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Kimberly Clark Corporation
General Hospital
103d
Cleared
Aug 24, 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
Shandong Yinghng Medical Products Co., Ltd.
General Hospital
402d
Cleared
Aug 16, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
New Era Medicare Sdn. Bhd.
General Hospital
191d
Cleared
Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
Shandong Intco Medical Products Co, Ltd.
General Hospital
88d
Cleared
Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
S&S Glove Corporation
General Hospital
86d
Cleared
Aug 09, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Grand Work Plastic Products Co., Ltd.
General Hospital
30d
Cleared
Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
Raxwell Industrial, LLC
General Hospital
33d