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

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
73–96 of 1170
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
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 Jul 04, 2023
MemorialTM Gloves
K231740
Us Glove Supply
General Hospital · 20d
Cleared Jun 09, 2023
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K230779
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital · 80d
Cleared Jun 06, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
K231349
Nephron Nitrile, LLC
General Hospital · 28d
Cleared Jun 05, 2023
APOLLO ADVANTAGE Nitrile Examination Gloves
K230633
Dell Corning Corporation
General Hospital · 90d
Cleared May 31, 2023
Disposable Nitrile Gloves (ABC-DG01)
K230542
Huizhou Anboson Technology Co., Ltd.
General Hospital · 92d
Cleared May 30, 2023
First Glove Blue Nitrile Examination Gloves Powder Free
K230958
First Glove Sdn. Bhd.
General Hospital · 56d
Cleared May 28, 2023
Blue Nitrile Examination Gloves Powder Free
K230601
Latrile Gloves Private Limited
General Hospital · 86d