alphatec-87-029_alphatec®-alphatec 87 029_eu_20231120_declaration of conformity

1. 2141A X2XXXX AKLMPT EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-029 Products manufactured as of: [2022/01/04] 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, 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 032/2021/0932, 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: 2022/01/04

3. AKLMPT 2141A X2XXXX EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-029 Products manufactured as of: [2019/01/21] and till: [2021/09/16] 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 374-1:2016, EN 388:2016, EN 407:2004, EN 420:2003 + A1:2009, 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 032/2019/0119, 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: 2019/01/21

2. 2141A X2XXXX AKLMPT EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-029 Products manufactured as of: [2021/09/17] and till: [2022/01/03] 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 EN 388:2016 +A1:2018, EN407:2020 , 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 032/2021/0932, 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: 2021/09/17

4. A K L 2241 X2XXXX EU DECLARATION OF CONFORMITY declare under their sole responsibility, that the PPE described hereafter: Astroflex Products manufactured till: [2019/01/20] 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 and authorized representative: COMASEC S.A.S 5 ALLÉE DES BAS TILLIERS 92238 GENNEVILLIERS CEDEX FRANCE is in conformity with the provisions of Regulation (EU) 2016/425 and with the standards EN 374:2003, , 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 0072/015/162/06/06/0058 issued by the Notified Body: IFTH – INSTITUT FRANÇAIS TEXTILE-HABILLEMENT (0072) AVENUE GUY DE COLLONGUE – 69134 ECULLY CEDEX – FRANCE and is subject to the procedure set out in Annex VIII (Module D) of the Regulation under the supervision of the Notified Body: BSI (0086) KITEMARK COURT DAVY AVENUE KNOWLHILL MILTON KEYNES MK5 8PP UNITED KINGDOM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2009/10/26