Skin Adhesive Technology
The base material is manufactured by 3M Company. The material is considered a medical grade nonwoven breathable tape with a gentle adhesive that contains no rubber Latex. Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics (1965). Published by the Editorial Committee of the Association of Food and Drug Officials of the United States.
It has been approved by the FDA as an approved Breathable Elastic Nonwoven Tape, suitable for use as adhesive on human skin that has been subjected to the following safety evaluations:
These tests are in accordance with the ISO 10933 Part-1 “Biological Evaluation of Medical Devices”, as put forth by the FDA. All laboratory testing was conducted in accordance with the FDA Good Laboratory Practices Regulation of 1978.
The use of the term “hypoallergenic” has come to indicate a product which is not sensitizing to the public. The hypoallergenic claim for this product is supported by clinical evaluation using the repeated insult patch test in humans, commonly known as the Draize test. This protocol involves repeated application of samples on 200 healthy volunteers for a 2- to 3-week induction period, followed by a 2-week rest period and a challenge application. To be termed hypoallergenic, 3M Medical Specialties products are required to show no evidence of sensitization potential under these test conditions. It is the responsibility of our customers to determine the final suitability of our products for their application.
In combination, the two materials laminated together is a process that 3M Company has perfected, along with the correct FDA adhesive made for all types of skin conditions, making this blend the perfect bio energy patch for human skin.
The patch material is also waterproof and is impervious to bacteria and perspiration from sweat glands and is also biodegradable.