Medical Device Manufacturer · MY , Klang Selangor Darul Ehsan

Bright Element Sdn Bhd - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2006

Recent clearances: ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES, ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE, ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bright Element Sdn Bhd General Hospital ✕

4 devices

1-4 of 4

Cleared Mar 02, 2007

ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES

General Hospital · 71d

Cleared Feb 23, 2007

ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE

General Hospital · 63d

Cleared May 24, 2006

ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES

General Hospital · 37d

Cleared May 19, 2006

BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES

General Hospital · 32d