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
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
Cleared
May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
Central Medicare Sdn Bhd
General Hospital
83d
Cleared
May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
Hartalega NGC Sdn. Bhd.
General Hospital
184d
Cleared
May 15, 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Careglove Global Sdn. Bhd.
General Hospital
118d
Cleared
May 08, 2023
Disposible Nitrile Gloves
Holik Asia Group Co.,Ltd
General Hospital
196d
Cleared
Apr 27, 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
295d
Cleared
Mar 30, 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Professional Latex Sdn Bhd
General Hospital
443d
Cleared
Mar 25, 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
Yty Industry (Manjung) Sdn Bhd
General Hospital
386d
Cleared
Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
Mah Sing Healthcare Sdn. Bhd.
General Hospital
80d
Cleared
Mar 23, 2023
Disposable Medical Nitrile Examination Gloves
Hebei Titans Hongsen Medical Technology Co., Ltd.
General Hospital
85d
Cleared
Mar 16, 2023
Nitrile Examination Gloves
Ecoglove Medical Manufacturing Company Limited
General Hospital
178d
Cleared
Mar 15, 2023
Tegamen Nitrile Examination Gloves
M/S Tegamen Safety Products Private Limited
General Hospital
166d
Cleared
Mar 15, 2023
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Kossan International Sdn Bhd3
General Hospital
131d
Cleared
Feb 13, 2023
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
Rhino Health, Inc.
General Hospital
52d