alphatec-csm-isolator-glove-85-304_alphatec®-85-304 _eu_20231114_declaration of conformity

5. AKL 4101 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 85-304 Products manufactured till: [2019/04/08] 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 374:2003, EN 388:2003 and is identical to the PPE which is subject to the EC Type examination; under certificate number IFA 1501064 issued by the Notified Body: INSTITUT FÜR ARBEITSSCHUTZ DER DGUV (IFA) (0121) PRÜF- UND ZERTIFIZIERUNGSSTELLE IM DGUV TEST ALTE HEERSTRASSE 111 53754 SANKT AUGUSTIN and is subject to the procedure set out in Annex VII (Module C2) of the Regulation under the supervision of the Notified Body: INSTITUT FÜR ARBEITSSCHUTZ DER DGUV (IFA) (0121) PRÜF- UND ZERTIFIZIERUNGSSTELLE IM DGUV TEST ALTE HEERSTRASSE 111 53754 SANKT AUGUSTIN Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2015/10/20

2. AMP EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 85-304 Products manufactured as of: [2021/01/12] 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 ISO 374-5:2016, EN ISO 374-1:2016 Type B and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2019/0665.03, 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: 2021/01/12

1. 3101A AMP EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 85-304 Products manufactured till: [2026/12/02] 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 +A1:2018, EN ISO 21420:2020, EN ISO 374-1:2016, EN ISO 374-5:2016 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2021/1308, 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: 2021/12/02

3. AMP EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 85-304 Products manufactured as of: [2020/11/16] and till: [2021/01/11] 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 ISO 374-5:2016, EN ISO 374-1:2016 Type B and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2019/0665.02, 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: 2020/11/16

4. AMP EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 85-304 Products manufactured as of: [2019/04/09] and till: [2020/11/15] 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 ISO 374-5:2016, EN ISO 374-1:2016 Type B and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2019/0665, 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: 2019/04/09