Are our plaster bandages safe and non-toxic?
Our plaster bandages are medical grade plaster bandages. They cost the same price, and often less than, art supply grade plaster bandages. The major differences are their testing and requirements by the FDA. All plaster bandages are imported from other countries. Currently, there is no known producer of plaster bandages in the United States. That being said, art supply companies do not have to submit their imported products to the FDA for testing of toxic chemicals or other manufacturing requirements, but medical suppliers do. It costs money for a company to be registered with the FDA, and since it is not required for an art supplier, most art supply companies choose to skip the testing and registration with the FDA.
With medical supplies, not only does the USA importing company have to register with the FDA, but so does the foreign company. This means that they are both held to high standards as required by the FDA on any imported products. When our plaster bandages get to the USA border, an FDA official checks to confirm that both companies are in compliance with standards. They also take a few samples of the product and do a series of chemical tests on the product to ensure the product is pure and safe for import. This is NOT the case with art supply plaster! Art supply companies do not have to be registered with any governing agency to ensure their product is safe. It is not tested each time the product is imported. So the next time you choose to buy plaster for face masks for a child's art project, or the next time you choose to do a belly cast. Think about which plaster you want to purchase. In addition, our plaster is gluten and latex free.
Our FDA medical registration can be seen at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=107913
If the link does not work you can go to:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
then search for K10 Medical Supply under the establishment name.