MeLuna is made from an Elastomer called TPE (thermoplastic elastomer).Elastomer refers to a natural or synthetic polymer that has elastic properties. Natural rubber for example is an elastomer. MeLuna TPE does not contain any Latex. Thermoplastic refers to the ability of the material to be molded under the application of heat and it retains its new shape when it cools without a change to the original properties of the material. Plasticity is a term that refers to changeability. By the application of heat the MeLuna can change its shape. TPE exists in many variants and is made with different components depending on application. Medical grade TPE has very little in common with TPE used for yoga mats for example. Our TPE is specifically manufactured for the medical device industry. The production is very closely monitored and only consists of components suitable for medical device applications.The material is manufactured by Kraiburg GmbH in Germany. It was developed especially for such highly sensitive applications and has passed the mucosal irritation test with flying colors. You may have encountered this material before in items such as pacifiers. The TPE used in MeLuna cups is BfR, FDA, 2002/72/EC and ISO 10993-10 certified.You can find more info about the raw material through the Kraiburg website here. https://www.kraiburg-tpe.com/en/thermolast-mThe Oko-Test Organization rated MeLuna as Sehr Gut (Very Good) in comparison with 21 other cups and tampons tested. You can view the full report here.