This product is far, far beyond FDA’s reach. The ultimate in OTC comfort! From the company’s website:
Once again we have adopted a product that has already been used in the Health Care Industry, and provided it to those who hate the waiting. It is called a Female Urinary Pouch. The pouch is Non-Latex, and contains an Odor-Barrier pouch film. At the bottom of the pouch is a Convenience Drain that connects to the leg bag system (worn on the inner calf). It is one size fits all, and is cut to fit one’s needs. Application is explained in the instruction guide.