What is Considered Medical Grade Foam?
Understanding the guidelines and definitions of what "medical-grade foam" is can be a daunting task. The term means many things to many different people. Here at UFP Technologies, we follow a simple set of guidelines and definitions which allow us to determine the most functional and economical foam to use in our customers’ medical products, components, and specialty packaging.
- Biocompatibility
The foam has been tested, passed and certified to comply with the ISO 10993 protocol. - FDA Master File
This is where foam formulations are registered with the FDA. It is important to remember that a foam with an FDA master file means that the formulation is registered with the FDA. It does not necessarily mean that the foam is “medical grade. Additional biocompatibility testing will determine whether or not the foam is appropriate for use in medical applications. - Fixed Formulation
The raw material formulation may be registered with the FDA. Should the material change, it is determined that the foam is not able to be categorized as a medical grade foam without additional testing. - 510K Submissions
We will work with the raw material supplier and customer to determine if the foam has previously been registered in a 510K application. - USP Classification
This is a raw material registration used primarily in the pharmaceutical industry.
UFP Technologies' sales and engineering teams pair your project’s requirements with the above classifications to ensure that we are providing you with a superior, technical foam solution. We are then equipped to engineer and fabricate an innovative solution for you at one of our ISO 13485:2003 manufacturing sites.
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