Are Our Plaster Bandages FDA-Registered and Safe?

Information provided by the OrthoTape team — FDA-registered medical casting supplier since 2005.

Medical-Grade vs. Art Supply Plaster Bandages

Our plaster bandages are medical-grade plaster bandages that cost the same — and often less — than art supply grade plaster bandages. The major differences come down to testing, safety standards, and FDA oversight.

All plaster bandages sold in the United States are imported from other countries. There is currently no known domestic producer of plaster bandages in the United States. However, art supply companies are not required to submit their imported products to the FDA for testing of toxic chemicals or other manufacturing requirements — but medical suppliers are.

Why FDA Registration Matters

Registering with the FDA costs money. Since it is not required for art suppliers, most art supply companies choose to skip the testing and registration process entirely. With medical supplies, the requirements are much stricter:

• The U.S. importing company must be registered with the FDA.
• The foreign manufacturing company must also be registered with the FDA.
• Both companies are held to high standards on any imported products.
• When our plaster bandages arrive at the U.S. border, an FDA official inspects the shipment and confirms both companies are in compliance.
• The FDA takes samples of the product and performs a series of chemical tests 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, and it is not tested each time the product is imported.

In addition, our plaster bandages are gluten-free and latex-free.

Verify Our FDA Registration

Our FDA medical registration can be verified directly on the FDA website:

• View OrthoTape FDA Registration (Direct Link)
• If the direct link does not work, go to FDA Establishment Registration Search and search for K10 Medical Supply under the establishment name.

Frequently Asked Questions: Plaster Bandage Safety

Are OrthoTape plaster bandages safe for skin contact?

Yes. Our plaster bandages are medical-grade, FDA-registered, and tested for purity and safety. They are also gluten-free and latex-free, making them suitable for patients with common sensitivities.

What is the difference between medical plaster and art supply plaster?

Medical plaster bandages must meet FDA registration and testing requirements for both the U.S. importer and the foreign manufacturer. Art supply plaster has no such requirements and is not tested for toxic chemicals or purity at the border. The price is often the same or lower for medical-grade plaster.

Is art supply plaster safe for face masks or belly casts?

Art supply plaster is not required to be tested for toxic chemicals or skin safety. For any application involving direct skin contact — especially for children or pregnant women — we strongly recommend using FDA-registered medical-grade plaster bandages.

Are your plaster bandages gluten-free and latex-free?

Yes. OrthoTape medical plaster bandages are both gluten-free and latex-free.

How can I verify your FDA registration?

You can verify our FDA registration at the FDA Establishment Registration database. Search for K10 Medical Supply at accessdata.fda.gov, or use the direct link: FDA Registration #107913.

Can I use medical plaster bandages for art projects?

Yes. Medical-grade plaster bandages work exactly the same as art supply plaster for sculpting, face masks, belly casts, and life casting — and they are safer because they have been tested for purity and toxic chemicals. The cost is typically the same or less.

Where can I buy FDA-registered medical plaster bandages?

OrthoTape sells FDA-registered medical-grade plaster bandages online. Browse our selection at orthotape.com/collections/plaster-bandages.