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
Cleared
Oct 02, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
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)
Isikel Manufacturing, LLC
General Hospital
83d
Cleared
Sep 29, 2023
Chemotherapy Gloves
3A Glove Sdn. Bhd.
General Hospital
185d
Cleared
Sep 21, 2023
Powder-Free Nitrile Examination Gloves
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)
Syntex Healthcare Products Co., Ltd.
General Hospital
95d
Cleared
Aug 31, 2023
Powder Free Nitrile Examination Gloves (Black)
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
Kimberly Clark Corporation
General Hospital
103d
Cleared
Aug 24, 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
Shandong Yinghng Medical Products Co., Ltd.
General Hospital
402d
Cleared
Aug 16, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
New Era Medicare Sdn. Bhd.
General Hospital
191d
Cleared
Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
Shandong Intco Medical Products Co, Ltd.
General Hospital
88d
Cleared
Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
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
Grand Work Plastic Products Co., Ltd.
General Hospital
30d
Cleared
Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
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
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
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
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
Central Medicare Sdn Bhd
General Hospital
112d
Cleared
Jul 04, 2023
MemorialTM Gloves
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
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)
Nephron Nitrile, LLC
General Hospital
28d
Cleared
Jun 05, 2023
APOLLO ADVANTAGE Nitrile Examination Gloves
Dell Corning Corporation
General Hospital
90d
Cleared
May 31, 2023
Disposable Nitrile Gloves (ABC-DG01)
Huizhou Anboson Technology Co., Ltd.
General Hospital
92d
Cleared
May 30, 2023
First Glove Blue Nitrile Examination Gloves Powder Free
First Glove Sdn. Bhd.
General Hospital
56d
Cleared
May 28, 2023
Blue Nitrile Examination Gloves Powder Free
Latrile Gloves Private Limited
General Hospital
86d