ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES


Device Classification Name

latex patient examination glove

510(k) Number K023974
Device Name ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES
Original Applicant
TOP GLOVE SDN. BHD.
lot 4968, bt 6, jalan teratai
off jalan meru
klang, selangor, 

MY

41050

Original Contact lim wee chai
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 12/02/2002
Decision Date 02/13/2003
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