POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM


Device Classification Name

latex patient examination glove

510(k) Number K030157
Device Name POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
Original Applicant
WRP ASIA PACIFIC SDN. BHD.
lot1,jalan3,kawasan perusahaan
bandar baru salak tinggi
sepang,selangor darul ehsan, 

MY

43900

Original Contact terence lim
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 01/16/2003
Decision Date 02/19/2003
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