What Is Medical Grade Silicone

Medical-grade silicones have undergone biocompatibility testing and are suitable for use in medical applications. The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) oversees the regulation of implants in the US. Other than specific dental materials, it does not control any other materials.

A class of goods known as medical-grade silicone has undergone extensive testing in clinical settings and is intended to interact safely with the human body. Medical silicone is difficult to identify and categorize due to its diverse applications. But it must first satisfy strict FDA requirements before being used in a medical setting. Medical silicone may be created for short-term or long-term use since it is reliable and secure. Medical-grade silicone is included in a variety of products, including tubes, dental retainers, implants, respiratory masks, and gel sheets for scar healing.

The Use Of Medical Grade Silicone Rubber

Medical Grade Silicone use

About Medical Grade Silicone Two Things

Many businesses refer to "medical grade silicone." One of two things can be inferred from this:

  1. Medical-long-term implantable material: This technical phrase refers to a substance that may be used in an implanted device and remain in the body. It is typically too costly for food-grade uses due to its purity.
  2. Medical-grade silicone, also known as class VI silicone or medical-healthcare grade silicone, is the material we prefer for a variety of items, such as menstruation cups, infant bottle nipples, scuba mouthpieces, water pipes, and food and skin contact devices.

Medical-long term implantable and medical-healthcare grade, Class VI, are both regarded as safe for food contact. Both grades are typically referred to as liquid silicone rubber (LSR), which is used in injection molding to produce precise, uniform products.

3 Types Of Silicone Rubber Available

We are aware of how crucial performance and processability are when creating premium materials for the healthcare industry. The medical grade silicones from the lgdsilicone line have exceptional mechanical qualities that make them perfect for the production of high-end medical components and equipment.

  • General-purpose liquid silicone rubber (LSR), biomedical liquid silicone rubber (LSR) used in long-term implant applications, and LSR for improved liquid injection molding
  • High consistency rubber (HCR) is used for long-term implant applications as well as general-purpose HCRs for extrusion and molding.
  • Room Temperature Vulcanizing (RTV) biocompatible, low viscosity silicones curing at room temperature into soft and durable elastomers

Benefit Of Medical Grade Silicone

  • Medical grade silicone FDA biocompatibility
  • Medical grade silicone is safe/sterile alternative to latex
  • Medical-grade silicone Gas permeability
  • Medical grade silicone High elongation
  • Medical grade silicone Ability to function in extreme temperatures
  • Silicone of a medical grade Low compression set at a variety of temperatures

What's the difference between medical grade silicone and regular silicone?

The curing procedure employed is the primary distinction between silicone that isn't medical grade and silicone that is. The peroxide cure system, also known as a free radical cure system or a high temperature vulcanizing (HTV) system, is used by traditional silicone.

Is medical grade silicone safe for skin?

Most people can safely use silicone. According to the Cosmetic Ingredient Review Expert Panel, silicone is safe to use in skin care products including moisturizers and patches.

What is the difference between food grade and medical grade silicone?

Food grade silicone is safe to use for food storage and cooking, as its names would imply. A step above from that is medical grade, which can be utilized in applications that come in contact with human tissue or touch human skin.

Can medical grade silicone grow bacteria?

Despite being biocompatible and biostable, silicone is susceptible to bacterial colonization.

Can medical grade silicone melt?

One of silicon's key characteristics is its ability to operate in situations with temperatures ranging from -60°C (-76°F) to 230°C (446°F). While most polymers start to melt at high temperatures, silicon has no melting point and only becomes solid when it burns.

What is medical grade silicone for scars?

Products for silicone scar therapy are made from medical-grade silicones. These silicones have passed certain tests to determine their biocompatibility (ability to be used in the body safely) and have been approved for use in medical applications.


To learn more about medical-grade Liquid Silicone Rubber or receive a free quote, contact LGDsilicone Group representative today.


About Frank

With a background as an injection molding engineer at Kaysun, Frank brings unique depth and insight to his role as Business Development Engineer. His ability to synthesize information and pair need with opportunity is a benefit to prospects and customers alike.

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