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 Medline Industries, Inc., O&M Halyard, Inc. and Shen Wei (Usa), Inc..

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
49–72 of 1170
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
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 Dec 15, 2023
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
K233182
Zibo Kaiyue Mould Technology Co., Ltd.
General Hospital · 78d
Cleared Dec 06, 2023
Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K233042
Shandong Intco Medical Products Co, Ltd.
General Hospital · 72d
Cleared Nov 28, 2023
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
K232252
Dehai (Shandong) Medical Gloves, Co., Ltd.
General Hospital · 123d
Cleared Nov 21, 2023
Medical Nitrile Examination Gloves
K232576
Jiangsu Complete Sincerity Medical New Materials Co., Ltd.
General Hospital · 88d
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 30, 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K231029
Zhonghong Pulin Medical Products Co., Ltd.
General Hospital · 202d
Cleared Oct 26, 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
K230662
Zhonghong Pulin Medical Products Co., Ltd.
General Hospital · 230d
Cleared Oct 20, 2023
Nitrile Examination Gloves, Dual Color Black-Blue
K232550
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital · 58d
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 06, 2023
Patient Examination Gloves
K230777
3A Glove Sdn. Bhd.
General Hospital · 199d
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