hyflex-48-101_hyflex®-48-101_eu_20231103_declaration of conformity

3. 2003 4131 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: Sensilite™ 48-101 Products manufactured till: [2018/04/20] 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 03205433 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: 2005/10/21

1. 4131A EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 48-101 Products manufactured as of: [2021/12/22] 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 032/2021/1424, 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: 2021/12/22

2. 2016 4131A EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 48-101 Products manufactured as of: [2018/04/21] and till: [2021/12/21] 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 032/2018/0512, 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: 2018/03/16