HyFlex_11-630_en_conformity (1)

1. Ansell Healthcare Europe N.V. Riverside Business Park Block J Tel. 32 (0)2-528 74 00 Boulevard International 55 B-1070 Brussels Fax 32 (0)2-528 74 01 EC DECLARATION OF PRODUCT CONFORMITY EC DECLARATION OF PRODUCT CONFORMITY Category II The manufacturer, established in the European Economic Community: ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS declares that the PPE described hereafter: HyFlex® 11-630 4443 is in conformity with the provisions of the Council Directive 89/686/EEC and with the European harmonised standards EN420:2003+A1:2009 & EN388: 2003, and is identical to the PPE which is subject to the EC Type Examination certificate number 3206055 issued by the Notified Body: CENTEXBEL TECHNOLOGIEPARK 7 B-9052 ZWIJNAARDE Thursday, 22 March 2018 Guido Van Duren Director – Global Regulatory Affairs PPE Products Ansell