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
Jul 07, 2025
Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
Zibo Shengkun Chemical Industry Co., Ltd.
General Hospital
137d
Cleared
Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
O&M Halyard, Inc.
General Hospital
261d
Cleared
Jun 17, 2025
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital
260d
Cleared
Jun 06, 2025
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
Mah Sing Healthcare Sdn. Bhd.
General Hospital
189d
Cleared
Jun 03, 2025
GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
Glove One, LLC
General Hospital
175d
Cleared
May 22, 2025
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Basic Medical Technology, Inc.
General Hospital
80d
Cleared
Apr 23, 2025
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
Gmp Medicare Sdn. Bhd.
General Hospital
26d
Cleared
Apr 01, 2025
Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Careglove Global Sdn. Bhd.
General Hospital
33d
Cleared
Mar 19, 2025
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
Safesource Direct, LLC
General Hospital
27d
Cleared
Mar 18, 2025
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co., Ltd.
General Hospital
204d
Cleared
Feb 18, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Basic Medical Technology, Inc.
General Hospital
70d
Cleared
Feb 06, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
Ever Global (Vietnam) Enterprise Corporation
General Hospital
38d
Cleared
Jan 31, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
Basic Medical Technology, Inc.
General Hospital
86d
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