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
49–72 of 1168
Cleared Feb 29, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
K240051
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
K233560
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Feb 13, 2024
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740
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
K240072
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
K232764
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
K233598
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)
K233970
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
K233520
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
K233405
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
K232538
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
K232461
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
K232266
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)
K232070
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)
K231567
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
K230681
Central Medicare Sdn Bhd
General Hospital · 203d
Cleared Sep 21, 2023
Powder-Free Nitrile Examination Gloves
K223214
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)
K231643
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
K231435
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
K232039
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
K223713
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
K223752
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
K231021
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
K230875
Central Medicare Sdn Bhd
General Hospital · 112d
Cleared May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
K230564
Central Medicare Sdn Bhd
General Hospital · 83d