The b balance kinesiology tape underwent a cytotoxicity test using L-929 mouse fibroblast cells. Under GLP conditions and ISO 10993-5 criteria, the tape was evaluated as grade 1 (slight cytotoxicity) with minimal cell growth inhibition observed.
The Buehler skin sensitization test evaluated kinesiology tape on guinea pigs, demonstrating no skin reactions, erythema, or sensitization. Conducted under GLP standards, the tape showed 0% sensitization rate, ensuring safe application without allergic responses.
The b balance tape underwent a skin irritation test in New Zealand White rabbits under GLP conditions. The results indicated negligible skin reactions (P.I.I = 0.0), confirming its safety for application without adverse effects.
The EC Declaration of Conformity certifies b balance kinesiology tape as compliant with MDR 2022/745 standards. It meets ISO 13485, ISO 14971, ISO 10993-5, and ISO 10993-10 requirements, ensuring safety, quality, and biocompatibility.
