We have had the fabric and bedding tested numerous times for skin sensitivity as it may relate to concerns from psoriasis/eczema sufferers. These tests included analyses of skin irritation, skin sensitization, and cytotoxicity. In all such testing, DermaTherapy showed passing results, with no cytotoxicity or sensitivity for at-risk skin. The FDA reviewed our test results and found them to pass standards for medical devices used in contact with the skin. In fact, the FDA cleared DermaTherapy as a Class I Medical Device for use by people suffering from psoriasis, eczema and atopic dermatitis.
* Standard No. ISO 10993-5, “Biological Assessment of Medical Products, Part 5: Tests for Cytotoxicity – MEM Elution; Version 10993-5”, Standard Date 01/01/1999
* Standard No. ISO 10993-10, “Biological Evaluation of Medical Devices – Part 10: Irritation: Intracutaneous Reactivity; Version 10993-10:2002(E)”, Standard Date 01/01/2002
* Standard No. ISO 10993-10, “Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Sensitization – Maximum Sensitization Test; Version10993-10:2002(E)”, Standard Date 01/01/2002
DermaTherapy fabrics are woven from a blend of polyester and nylon yarns.
DermaTherapy fabrics are woven from a strong, continuous-filament yarn that creates a consistently smooth, silk-like surface. Our fabrics are lint free, and release almost no lint or contaminating particles that can irritate the skin and infiltrate pores. Friction and skin abrasiveness are virtually eliminated.