SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR


Device Classification Name

polymer patient examination glove

510(k) Number K022784
Device Name SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE 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
LZA  
Date Received 08/22/2002
Decision Date 11/13/2002
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