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., O&M Halyard, Inc. and Basic Medical Technology, Inc..
1168
Total
1168
Cleared
117d
Avg days
1984
Since
1168 devices
Cleared
Jan 15, 2025
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Sunray Medical Products, Inc.
General Hospital
112d
Cleared
Jan 08, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
27d
Cleared
Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
O&M Halyard, Inc.
General Hospital
111d
Cleared
Oct 25, 2024
Nitrile Powder Free Examination Gloves Biodegradable (Green)
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
268d
Cleared
Oct 12, 2024
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
Nb Medical Company Limited
General Hospital
24d
Cleared
Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
O&M Halyard, Inc.
General Hospital
88d
Cleared
Sep 11, 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
Ksg Medicare Sdn. Bhd.
General Hospital
85d
Cleared
Aug 28, 2024
GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
Genabio Diagnostics, Inc.
General Hospital
183d
Cleared
Aug 23, 2024
Cardinal Health Nitrile Exam Gloves
Cardinal Health200, LLC
General Hospital
64d
Cleared
Aug 06, 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
68d
Cleared
Aug 02, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
Kanglongda Vietnam Protection Technology Company Limited
General Hospital
28d
Cleared
Jul 02, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
89d
Cleared
Jun 25, 2024
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
Ningxia Qiaoen Medical Technology Co., Ltd.
General Hospital
91d
Cleared
May 28, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Xingyu Medical Tech Co., Ltd.
General Hospital
83d
Cleared
May 13, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
259d
Cleared
Apr 22, 2024
Black Pearl Nitrile Examination Glove
Ug Global Resources Sdn. Bhd.
General Hospital
263d
Cleared
Apr 08, 2024
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Yue Kang Anhui Medical Products Co., Ltd.
General Hospital
96d
Cleared
Apr 04, 2024
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL)
Hebei Titans Hongsen Medical Technology Co., Ltd.
General Hospital
58d
Cleared
Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Syntex Healthcare Products Co., Ltd.
General Hospital
82d
Cleared
Apr 01, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
Shandong Xingyu Gloves Co., Ltd.
General Hospital
105d
Cleared
Mar 27, 2024
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Ever Growth (Vietnam) Corporation Limited
General Hospital
92d
Cleared
Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
O&M Halyard, Inc.
General Hospital
266d
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