PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)


Device Classification Name

surgeon’s gloves

510(k) Number K021784
Device Name PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
Original Applicant
WRP ASIA PACIFIC SDN. BHD.
lot1,jalan3,kawasan perusahaan
bandar baru salak tinggi
sepang,selangor, 

MY

43900

Original Contact yue wah chow
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 05/30/2002
Decision Date 07/24/2002
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