POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR


Device Classification Name

polymer patient examination glove

510(k) Number K023072
Device Name POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
Original Applicant
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
128 jalan kyai haji muhammad
mansyur
jakarta barat, 

ID

11210

Original Contact linga sumarta
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 09/16/2002
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