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, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs, POWDER FREE 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