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Please see breakdown below of the 144,000,000 in the following sizes: Small (S) 48,000,000 Medium (M) 66,600,000 Large (L) 28,000,000 Extra Large (XL) 1,400,000 The Nitrile Examination Gloves must meet the following standards; • Will be CE marked • The manufacturer must be certified ISO 13485 • Packaging must be in English and clearly state ‘EN455’ • Product must be certified EN455: and meet, or exceed, the following technical requirements: o EN455: 1 – Freedom from Holes o EN455: 2 – Physical Properties o EN455: 3 – Biological Evaluation Prior to deliver the Factory must provide: • Technical documentation demonstrating conformity to the Medical Device Directive (MDD) • Provide the EC Declaration of Conformity • Clinical evaluation, including test reports in line with the requirements of the MDD
