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., Hartalega Sdn Bhd and Hartalega NGC Sdn. Bhd..

1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
25–48 of 1181
Cleared Jul 07, 2025
Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
K250496
Zibo Shengkun Chemical Industry Co., Ltd.
General Hospital · 137d
Cleared Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
K243172
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
K243133
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
K243694
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]
K243796
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
K250630
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
K250944
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)
K250578
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)
K250502
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
K242533
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)
K243792
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
K244034
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)
K243441
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
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