hyflex-70-750_hyflex®-70-750_eu_20231113_declaration of conformity

1. 2X4XD X1XXXX EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 70-750 Products manufactured as of: [2021/10/01] PPE to be used against category III 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, EN407:2020 , 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 032/2021/0990, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VII (Module C2) of the Regulation under the supervision of the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2021/10/01

3. 154X X1XXXX EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: Vantage™ 70-750 Products manufactured till: [2019/05/13] PPE to be used against category III 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 407:2004, EN 420:2003 + A1:2009 and is identical to the PPE which is subject to the EC Type examination; under certificate number 032/2015/0553 issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VII (Module C2) of the Regulation under the supervision of the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2015/05/12

2. 2X4XD X1XXXX EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 70-750 Products manufactured as of: [2019/05/14] and till: [2021/09/30] PPE to be used against category III 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 407:2004, 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 032/2019/0905.02, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VII (Module C2) of the Regulation under the supervision of the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2019/05/14