VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)


Device Classification Name

polymer patient examination glove

510(k) Number K080066
Device Name VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
Applicant
GX CORPORATION SDN BHD
lot 6487, batu 5 3/4, sementa
jalan kapar
klang, selangor, 

MY

42100

Applicant Contact foo khon pu
Correspondent
GX CORPORATION SDN BHD
lot 6487, batu 5 3/4, sementa
jalan kapar
klang, selangor, 

MY

42100

Correspodent Contact foo khon pu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 01/10/2008
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No