VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E


Device Classification Name

vinyl patient examination glove

510(k) Number K023753
Device Name VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
Original Applicant
ARISTA LATINDO INDUSTRIAL LTD. P.T
jl k. h. moh mansyur no. 128
jakarta, 

ID

11210

Original Contact linga sumarta
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 11/08/2002
Decision Date 03/25/2003
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