POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM


Device Classification Name

surgeon’s gloves

510(k) Number K021119
Device Name POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & 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 kk leong
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 04/08/2002
Decision Date 07/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No