Style AG50MED is a 50 durometer medical grade silicone gasketing material, which is formulated for use in health care applications. The base silicone polymer in this premium grade silicone has been tested to meet the standards of UPS Class 6. A non-toxic and chemically inert material, AG50MED is manufactured with FDA approved ingredients listed in CFR 117.2600, an FDA regulation which involves rubber articles intended for repeated use in contact with food. 50 durometer medical grade silicone is a low volatile, peroxide free, platinum cured material that will not discolor over time. AG50MED performs in extreme low and high temperature, with a service temperature range of -80°F to +450°F. In addition to being a UV and ozone resistant material, 50 durometer medical grade silicone is able to pass the flammability rating of UL94 HB.
Atlantic Gasket’s medical grade silicone gasketing material is available in a wide range of durometers, ranging from as soft as 40 Durometer (AG40MED) to as hard as 70 Durometer (AG70MED) with standard durometers in between. Additional durometers are available upon request. Style AG50MED can be produced in rolls ranging from as narrow as 1/4" wide, up to 36" in width. Atlantic Gasket can supply 50 durometer medical grade silicone without adhesive or with either our standard acrylic adhesive or our high-temperature acrylic adhesive. 50 durometer medical grade silicone can be manufactured to a wide range of standard and custom thicknesses. Atlantic Gasket has the ability to fabricate 50 durometer medical grade silicone by die-cutting or waterjet cutting to meet your requirements and can provide support from the design stage through the production phase.
USP CLASS 6
21 CFR 177.2600
|Physical Property||Test Method||Unit of Measure||Typical Properties|
|DUROMETER||ASTM D 2240||SHORE A||50|
|TENSILE STRENGTH||ASTM D 412||psi||1200|
|SPECIFIC GRAVITY||ASTM D 297||G/CC||1.15|
|TEAR||ASTM D 624||ppi
|ELONGATION||ASTM D 412||%||600|
We provide materials to customers who engineer of fabricate products for health care applications. Health care applications are defined as after sales uses such as pharmaceutical production and/or delivery systems, medical devices, and dental and optical applications. We do not promote the use of our materials in which the material is implanted into the body. The above values are typical properties and are provided for information only. They should not be utilized to set specification requirements. This information is furnished as a guide for selecting materials. Atlantic Gasket Corp. disclaims liability for results or use of this information. It is the solely the customer’s responsibility to obtain and test samples when determining suitability of material for a particular application.
Click here to download a specification Word document.