Medical Device Manufacturer · MY , Kapar, Selangor D.E.

Great Glove Sdn Bhd - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1999

Recent clearances: NITRILE BLUE POWDERED EXAMINATION GLOVES, NITRILE BLUE POWDER FREE EXAMINATION GLOVE, GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Jan 19, 2006

NITRILE BLUE POWDERED EXAMINATION GLOVES

General Hospital · 90d

Cleared Dec 21, 2005

NITRILE BLUE POWDER FREE EXAMINATION GLOVE

General Hospital · 61d

Cleared Apr 10, 2002

GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS...

General Hospital · 65d

Cleared Dec 20, 1999

LATEX EXAMINATION POWDERED GLOVES

General Hospital · 73d