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 Medline Industries, Inc., O&M Halyard, Inc. and Shen Wei (Usa), Inc..
1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
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
Cleared
Feb 10, 2023
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Top Glove Medical (Thailand) Co., Ltd.
General Hospital
207d
Cleared
Feb 09, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
Nephron Pharmaceuticals Corporation
General Hospital
73d
Cleared
Feb 06, 2023
Powder Free Blue Nitrile Examination Glove
S&S Glove Corporation
General Hospital
84d
Cleared
Jan 27, 2023
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102)
Semperit Investments Asia Pte , Ltd.
General Hospital
30d
Cleared
Jan 26, 2023
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Mah Sing Healthcare Sdn. Bhd.
General Hospital
77d
Cleared
Jan 22, 2023
Synthetic Polymer Glove - Polyethylene (Black)
Ur Industry Sdn Bhd
General Hospital
153d
Cleared
Jan 19, 2023
Disposable Nitrile Examination Glove
Yangzhou Saraguard Medical Supplies Co., Ltd.
General Hospital
90d
Cleared
Jan 13, 2023
Non-Sterile Powder Free Nitrile Examination Gloves
Dynacare Sdn Bhd
General Hospital
88d
Cleared
Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
Us Medical Glove Company, LLC
General Hospital
30d
Cleared
Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Iconic Medicare Sdn Bhd
General Hospital
173d
Cleared
Jan 04, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Rmkh Glove (Cambodia) Co., Ltd.
General Hospital
100d