alphatec-87-950_alphatec®-87-950_eu_20231120_declaration of conformity

5. AKL X121 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: Extra 87-950 Products manufactured till: [2018/11/28] 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 420:2003 + A1:2009, EN 388:2003, and is identical to the PPE which is subject to the EC Type examination; under certificate number 032/2016/1179 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: 2016/11/24

1. X121X AKLOPS EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-950 Products manufactured as of: [2022/01/13] 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 388:2016 +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 032/2022/0029, 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: 2022/01/13

4. AKLOPS X121X EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-950 Products manufactured as of: [2018/11/29] and till: [2019/07/24] 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 420:2003 + A1:2009, EN ISO 374-5:2016, EN ISO 374-1:2016, EN 388:2016 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2018/1096, 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: BSI (0086) KITEMARK COURT DAVY AVENUE KNOWLHILL MILTON KEYNES MK5 8PP UNITED KINGDOM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2018/11/29

2. AKLOPS X121X EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-950 Products manufactured as of: [2019/07/31] and till: [2022/01/12] 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 420:2003 + A1:2009, EN ISO 374-5:2016, EN ISO 374-1:2016, EN 388:2016 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2018/1096, 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: 2019/07/31

3. AKLOPS X121X EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-950 Products manufactured as of: [2019/07/25] and till: [2019/07/30] 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 420:2003 + A1:2009, EN ISO 374-5:2016, EN ISO 374-1:2016, EN 388:2016 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2018/1096, 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: BSI GROUP THE NETHERLANDS B.V. (2797) SAY BUILDING, JOHN M. KEYNESPLEIN 9, 1066 EP AMSTERDAM NETHERLANDS Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2019/07/25