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
Mar 20, 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
Nephron Nitrile, LLC
General Hospital
202d
Cleared
Mar 01, 2024
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
Anhui Intco Medical Products Co., Ltd.
General Hospital
295d
Cleared
Feb 29, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
Lingshi Hongruida Health Protection Technology Co., Ltd.
General Hospital
52d
Cleared
Feb 26, 2024
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
Eco Medi Glove Sdn. Bhd.
General Hospital
112d
Cleared
Feb 13, 2024
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
W.A. Rubbermate Co., Ltd.
General Hospital
83d
Cleared
Feb 09, 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
Luliang Hongruida Health Protection Technology Co., Ltd.
General Hospital
30d
Cleared
Feb 07, 2024
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Eco Medi Glove Sdn. Bhd.
General Hospital
152d
Cleared
Jan 26, 2024
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
Anhui Intco Medical Products Co., Ltd.
General Hospital
78d
Cleared
Jan 16, 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
Nephron Nitrile, LLC
General Hospital
32d
Cleared
Jan 12, 2024
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Anhui Powerguard Technology Co., Ltd.
General Hospital
72d
Cleared
Dec 28, 2023
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
Eco Medi Glove Sdn. Bhd.
General Hospital
84d
Cleared
Dec 15, 2023
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
Zibo Kaiyue Mould Technology Co., Ltd.
General Hospital
78d
Cleared
Dec 06, 2023
Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Shandong Intco Medical Products Co, Ltd.
General Hospital
72d
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