SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR


Device Classification Name

latex patient examination glove

510(k) Number K023826
Device Name SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
Original Applicant
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
no. 1 fanjiazhung industrial
zone
xinji city, hebei province, 

CN

052360

Original Contact tan swu choon
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 11/18/2002
Decision Date 01/24/2003
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