Specific foams for Medical Devices or medical applications.
What is a medical device?
It could be a simple tongue depressor or as sophisticated as a pacemaker. A medical device, after the FDA definition, is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
The choice of reliable suppliers that can help with regulatory compliance and deliver consistent results, is a critical point of your design process.
Foam creations has -among its proprietary XL EXTRALIGHT® range of foams- some that are aimed to Home Medical Equipment (HME) and Durable Medical Equipment (DME) and even passed biocompatibility tests, such as ISO 10993.
If you need more information and guidance on your foam selection for human interface foams for medical devices, do not hesitate to contact us.
Our XL EXTRALIGHT® mark insures:
1. 100% North American compounded and manufactured product quality exclusively by Foam Creations, differentiating your product from overseas low quality competitors.
2. Vinyl free compound ingredients, and with higher physical properties.
3. Quality consistency in the foam industry since 1995.
4. Leading polyolefin foam mark in the USA, for quality , comfort, dependability and innovation, that customers recognize. We stand behind our brand.
5. Being part of an always growing group of worldwide product developers that locally produces high quality products. These products are for the most part of high added value, share somehow complementary values and hold best-in-class status. (You can check out some of the brands you are associating with in here).