hyflex-11-618_hyflex®-11-618_eu_20231102_declaration of conformity

3. 3121 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-618 Products manufactured till: [2019/07/04] PPE to be used against category II risks The Manufacturer ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS BELGIUM ® is in conformity with the provisions of Regulation (EU) 2016/425 and with the standards EN 388:2003, EN 420:2003 + A1:2009 and is identical to the PPE which is subject to the EC Type examination; under certificate number 03206191 issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VI (Module C) of the Regulation. Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2006/04/25

1. 3121X EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-618 Products manufactured as of: [2022/03/18] PPE to be used against category II risks The Manufacturer ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS BELGIUM ® is in conformity with the provisions of Regulation (EU) 2016/425 and with the standards EN 388:2016 +A1:2018, EN ISO 21420:2020 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2022/0424, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VI (Module C) of the Regulation. Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2022/03/18

2. 3121X EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-618 Products manufactured as of: [2019/07/05] and till: [2022/03/17] PPE to be used against category II risks The Manufacturer ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS BELGIUM ® is in conformity with the provisions of Regulation (EU) 2016/425 and with the standards EN 388:2016, EN 420:2003 + A1:2009 and is identical to the PPE which is subject to the EU- Type examination (Module B, Annex V of the Regulation), under certificate number 032/2019/0655, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VI (Module C) of the Regulation. Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2019/04/08