OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E


Device Classification Name

vinyl patient examination glove

510(k) Number K023452
Device Name OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E
Original Applicant
CANOPUS MEDICAL SUPPLY CO., LTD.
201 fu-hsing north rd., 10th
fl.
taipei, 

TW

105

Original Contact ruby lin
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 10/15/2002
Decision Date 11/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No