POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)


Device Classification Name

polymer patient examination glove

510(k) Number K081315
Device Name POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)
Applicant
GX CORPORATION SDN BHD
lot 6487, batu 5 3/4, sementa
jalan kapar
klang, 

MY

42100

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

MY

42100

Correspodent Contact foo k pu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/09/2008
Decision Date 08/11/2008
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