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
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
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 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 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
Cleared
Oct 02, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
Central Medicare Sdn Bhd
General Hospital
203d
Cleared
Sep 21, 2023
Powder-Free Nitrile Examination Gloves
Global Protection Corp.
General Hospital
339d
Cleared
Sep 08, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Syntex Healthcare Products Co., Ltd.
General Hospital
95d
Cleared
Aug 28, 2023
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Kimberly Clark Corporation
General Hospital
103d
Cleared
Aug 09, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Grand Work Plastic Products Co., Ltd.
General Hospital
30d
Cleared
Aug 07, 2023
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co., Ltd.
General Hospital
238d
Cleared
Jul 24, 2023
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
Central Medicare Sdn Bhd
General Hospital
221d
Cleared
Jul 21, 2023
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Kimberly Clark Corporation
General Hospital
102d
Cleared
Jul 20, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
Central Medicare Sdn Bhd
General Hospital
112d
Cleared
May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
Central Medicare Sdn Bhd
General Hospital
83d