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
73–96 of 1181
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
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 Oct 02, 2023
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
K232064
Isikel Manufacturing, LLC
General Hospital · 83d
Cleared Sep 29, 2023
Chemotherapy Gloves
K230847
3A Glove Sdn. Bhd.
General Hospital · 185d
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 31, 2023
Powder Free Nitrile Examination Gloves (Black)
K232353
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital · 24d
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 24, 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
K222103
Shandong Yinghng Medical Products Co., Ltd.
General Hospital · 402d
Cleared Aug 16, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K230314
New Era Medicare Sdn. Bhd.
General Hospital · 191d
Cleared Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408
Shandong Intco Medical Products Co, Ltd.
General Hospital · 88d
Cleared Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439
S&S Glove Corporation
General Hospital · 86d
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 08, 2023
Disposable Medical Examination Nitrile Gloves
K232008
Raxwell Industrial, LLC
General Hospital · 33d