DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE


Device Classification Name

polymer patient examination glove

510(k) Number K022904
Device Name DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
Original Applicant
WRP ASIA PACIFIC SDN. BHD.
lot 1, jalan 3,
kawasan perusahaan bandar baru
salak tinggi, sepang selangor, 

MY

43900

Original Contact yue wah chow
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 09/03/2002
Decision Date 10/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No