VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E


Device Classification Name

vinyl patient examination glove

510(k) Number K023754
Device Name VINYL EXAMINATION GLOVES, POWDER-FREE 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 11/06/2002
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