ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES


Device Classification Name

latex patient examination glove

510(k) Number K033530
Device Name ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
Applicant
ASIA PACIFIC LATEX SDN BHD
lot 12, medan tasek,
tasek industrial estate
ipoh perak, 

MY

31400

Applicant Contact lee son hong
Correspondent
ASIA PACIFIC LATEX SDN BHD
lot 12, medan tasek,
tasek industrial estate
ipoh perak, 

MY

31400

Correspodent Contact lee son hong
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 11/10/2003
Decision Date 01/28/2004
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