LZA · Class I · 21 CFR 880.6250

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
25–48 of 1168
Cleared Jan 15, 2025
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K242936
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)
K243818
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
K242558
O&M Halyard, Inc.
General Hospital · 111d
Cleared Oct 25, 2024
Nitrile Powder Free Examination Gloves Biodegradable (Green)
K240269
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 268d
Cleared Oct 12, 2024
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
K242812
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
K241909
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)
K241745
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)
K240545
Genabio Diagnostics, Inc.
General Hospital · 183d
Cleared Aug 23, 2024
Cardinal Health Nitrile Exam Gloves
K241780
Cardinal Health200, LLC
General Hospital · 64d
Cleared Aug 06, 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
K241528
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)
K241970
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
K240930
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)
K240824
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
K240629
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)
K232614
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 259d
Cleared Apr 22, 2024
Black Pearl Nitrile Examination Glove
K232319
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
K240021
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)
K240361
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
K240080
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)
K233990
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
K234097
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
K231938
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)
K232654
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
K231365
Anhui Intco Medical Products Co., Ltd.
General Hospital · 295d