SURGI GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K073447
Device Name SURGI GLOVES
Applicant
METACURE SURGICAL GLOVES SDN BHD
no. 1, jln 203, off jalan
tandang
petaling jaya, 

MY

46050

Applicant Contact jefri sharaai
Correspondent
METACURE SURGICAL GLOVES SDN BHD
no. 1, jln 203, off jalan
tandang
petaling jaya, 

MY

46050

Correspodent Contact jefri sharaai
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 12/07/2007
Decision Date 04/24/2008
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