Medical Device Manufacturer · MY , 41050 Klang, Selangor

Maxter Glove Manufacturing Sdn Bhd - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2001

Recent clearances: Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Maxter Glove Manufacturing Sdn Bhd General Hospital ✕

9 devices

1-9 of 9

Cleared May 02, 2018

Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with...

General Hospital · 224d

Cleared May 02, 2016

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

General Hospital · 342d

Cleared Feb 06, 2012

POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

General Hospital · 110d

Cleared Feb 24, 2004

MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES

General Hospital · 29d

Cleared Oct 17, 2003

MAXTER STERILE POWDER FREE SURGICAL GLOVES

General Hospital · 65d

Cleared Oct 10, 2003

MAXTER STERILE POWDERED LATEX SURGICAL GLOVES

General Hospital · 60d

Cleared Jan 17, 2002

CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN...

General Hospital · 87d

Cleared Jan 17, 2002

POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN...

General Hospital · 84d

Cleared Nov 29, 2001

POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS...

General Hospital · 43d