LATEX GLOVES non sterile, powder-free Class I We declare that the above mentioned product satisfies the requirements laid down in MDD 93/42/EEC, as amended by the Council directive 2007/47/EC. Requirements of the EN 455 parts 1, 2, 3, 4: • Water tightness test: gloves shall not leak when tested in accordance with clause 5. Sample size and allowable number on non-conforming gloves in accordance with ISO 2859-1, general inspection level I, AQL 1.5 • Tests werd performed on gloves to ensure an acceptable performance of the products (physical and biological tests). • The product passed all quality inspection methods in accordance with shelf life determination requirements. The gloves are manufactured according to ISA 13485:2003 and EN ISO 13485:2012 Quality Management Systems and are certified by TUV SUD America Inc. 10 Centenial Drive Peabody, MA 01960 USA. Akzenta International SA Chiasso, 01.01.2018 Signature and stamp: Printed name: Position: Luciana Piacquadio Head of office AKZENTA INTERNATIONAL SA VIA GIUSEPPE MOTTA 24 | CH-6830 CHIASSO VISIT US AT WWW.AKZENTA.COM VAT NO. CHE-337.693.284 IVA GENERAL MANAGER: DR. JOACHIM MISSFELDT COMPANY NO CHE-33