Published October 11, 2023

What Is Considered Medical Grade Foam

medical grade foam

Searching the Internet for a foam deemed “medical grade” can be an intimidating and discouraging mission. This is especially true when the search results yield an overwhelming amount of similar buzz words to decipher and distinguish (i.e. medical foam, medical grade foam, foam used in medical products, etc.). The term “medical grade” foam means many things to many different people. Here at UFP MedTech, 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 applications.  Below are the most common foam definitions we use to help select the correct material for your project:

  • Biocompatibility
    The foam has been tested, passed and certified to comply with the ISO 10993 protocol.
  • 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.
  • 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.
  • 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 MedTech’s 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 certified manufacturing sites. The ISO 13485 certification is a method of systems and documentation to ensure that the manufacturer does not change the raw material or the methods of fabricating during the manufacturing process. Choosing to keep the production within an ISO 13485 facility is becoming an industry standard. After all, the investment of time and economics has already been made to determine the appropriate medical grade foam.

Read More Articles

April 8, 2024

Materials Matter: 4 Reasons to Partner With an Expert

April 2, 2024

Aseptic Presentation: The Importance of Ease of Use When Designing Sterile Barrier Packaging

March 13, 2024

Medical Device Production Validation: 5 Things You Should Know

March 7, 2024

An Increased Need for Infection Prevention: 5 Key Steps to Developing and Manufacturing a Surgical Robot Drape System

November 6, 2023

Maximizing Speed & Efficiency in Today’s Medical Device Environment