SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM


Device Classification Name

latex patient examination glove

510(k) Number K021059
Device Name SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
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 04/02/2002
Decision Date 05/14/2002
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