... surgical sutures have already obtained the 510(k) from USA FDA, ISO 9001 ,and we are also CE certified ARC PDO ... . When dyed (violet), only FDA approved color additives such as D&C Violet #2 (Code of Federal Register,Title 21.74.3602 ... .Our sutures have already obtained the 510(k)from USA FDA, ISO 9001,and we are also CE certified. Feasures:1 ... , 2/0, 0, 1. Surgical Sutures (PDO) with CE and FDA