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
49–72 of 1181
Cleared Jul 02, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue
K240930
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 89d
Cleared Jun 25, 2024
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
K240824
Ningxia Qiaoen Medical Technology Co., Ltd.
General Hospital · 91d
Cleared May 28, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
K240629
Xingyu Medical Tech Co., Ltd.
General Hospital · 83d
Cleared May 13, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
K232614
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 259d
Cleared Apr 22, 2024
Black Pearl Nitrile Examination Glove
K232319
Ug Global Resources Sdn. Bhd.
General Hospital · 263d
Cleared Apr 08, 2024
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K240021
Yue Kang Anhui Medical Products Co., Ltd.
General Hospital · 96d
Cleared Apr 04, 2024
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL)
K240361
Hebei Titans Hongsen Medical Technology Co., Ltd.
General Hospital · 58d
Cleared Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K240080
Syntex Healthcare Products Co., Ltd.
General Hospital · 82d
Cleared Apr 01, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
K233990
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 105d
Cleared Mar 27, 2024
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K234097
Ever Growth (Vietnam) Corporation Limited
General Hospital · 92d
Cleared Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
K231938
O&M Halyard, Inc.
General Hospital · 266d
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