LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED


Device Classification Name

latex patient examination glove

510(k) Number K021412
Device Name LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
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
LYY  
Date Received 05/03/2002
Decision Date 06/07/2002
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