hyflex-11-840_hyflex®-11-840_eu_20231106_declaration of conformity

3. 4231 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-840 Products manufactured till: [2020/12/20] 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 03213141 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: 2013/01/29

1. X1XXXX 4131A EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-840 Products manufactured as of: [2022/06/03] 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 EN407:2020 , EN ISO 21420:2020, EN 388:2016 +A1:2018 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2022/0622, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VIII (Module D) 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: 2022/06/03

2. 4131A X1XXXX EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-840 Products manufactured as of: [2020/12/21] and till: [2022/06/02] 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 420:2003 + A1:2009, EN 407:2004 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2020/1533, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VIII (Module D) 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: 2020/12/21