What Is Medical-Grade Silicone? A Complete Guide

This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional for personal guidance.

If you have been researching intimate wellness products, you have probably come across the term "medical-grade silicone." It sounds reassuring, but what does it actually mean? How is it different from the silicone in your phone case or kitchen spatula? And why do wellness experts consider it the gold standard for products that come into contact with sensitive areas of the body? This guide breaks down everything you need to know — from how medical-grade silicone is manufactured to why it matters for your health and comfort.

What Defines Medical-Grade Silicone?

The term "medical-grade" is not just a marketing phrase — it refers to a specific classification of silicone that has passed standardised biocompatibility testing. The most widely recognised standard is USP Class VI, established by the United States Pharmacopeia.

USP Class VI testing evaluates a material through a series of biological assessments, including:

• Acute systemic toxicity tests: Ensuring the material does not release harmful substances into the body.
• Intracutaneous reactivity tests: Checking that the material does not cause skin irritation or inflammatory responses.
• Implantation tests: Verifying that the material is safe even when placed in direct contact with living tissue for extended periods.

Only silicone that passes all of these tests can be legitimately called medical-grade. This rigorous process is why medical-grade silicone costs significantly more to produce than standard industrial or food-grade silicone.

How Medical-Grade Silicone Is Made

There are two primary methods for curing (hardening) silicone:

Platinum-Cured (Addition Cure)

This is the method used for medical-grade silicone. A platinum catalyst drives the curing process, and the chemical reaction is remarkably clean — it produces no byproducts. The result is an exceptionally pure, stable material that will not leach chemicals over time, even when exposed to body heat and moisture. Platinum-cured silicone is sometimes called "addition-cured" silicone in technical contexts.

Peroxide-Cured (Condensation Cure)

This older, less expensive method uses peroxide as a catalyst. The curing reaction produces byproducts that must be removed through a post-curing process. If this step is incomplete, residual chemicals can remain in the material. Peroxide-cured silicone is common in industrial applications but is not considered suitable for prolonged intimate contact.

Medical-Grade Silicone vs. Other Common Materials

To understand why medical-grade silicone matters, it helps to compare it with other materials commonly found in intimate products — particularly budget options sold on online marketplaces.

TPE (Thermoplastic Elastomer)

TPE is a soft, flexible plastic that is significantly cheaper to manufacture than silicone. While it is generally considered less harmful than PVC, TPE is porous — meaning it has microscopic surface openings that can trap bacteria and are impossible to fully sterilise. TPE also degrades faster than silicone and may become sticky or break down over time. It is not a suitable substitute for medical-grade silicone in intimate products.

PVC (Polyvinyl Chloride) and "Jelly Rubber"

PVC is a hard plastic that requires the addition of chemical plasticisers — most commonly phthalates — to make it soft and flexible. Phthalates are classified as endocrine disruptors and are a significant health concern when used in products that contact sensitive skin. "Jelly rubber" is essentially PVC with heavy plasticiser content. It is porous, difficult to clean, and often has a strong chemical odour. Multiple consumer safety organisations have raised concerns about jelly rubber products.

Latex

Natural latex rubber is used in many consumer products, but it is a known allergen. Latex allergies are relatively common and can cause reactions ranging from mild skin irritation to severe anaphylaxis. Medical-grade silicone is inherently latex-free and hypoallergenic, making it safe for individuals with latex sensitivities.

ABS Plastic

ABS (Acrylonitrile Butadiene Styrene) is a rigid, non-porous plastic that is generally considered body-safe for external components like handles or bases. However, it lacks the flexibility and soft-touch feel of silicone, so it is typically used only for structural parts rather than surfaces that contact the body directly.

Why Medical-Grade Silicone Is Ideal for Intimate Products

The properties of medical-grade silicone align perfectly with what you need from any product that touches sensitive areas of your body:

• Non-porous surface: Bacteria, fungi, and other pathogens cannot penetrate the surface, allowing for thorough cleaning.
• Hypoallergenic: Extremely unlikely to cause allergic reactions or irritation, even on sensitive skin.
• Chemical stability: Does not leach chemicals, even at body temperature or in the presence of moisture.
• Durability: Retains its shape, colour, and texture over years of use without degrading.
• Temperature resilience: Can be safely warmed or cooled without releasing harmful substances.
• Odourless and tasteless: Pure platinum-cured silicone has virtually no smell, unlike TPE or PVC products.

The Indian Context

India does not yet have a specific regulatory framework governing the materials used in intimate wellness products. Unlike the European Union, which has comprehensive regulations on chemical safety for consumer products (REACH), or the United States, where the FDA oversees certain categories of personal care devices, the Indian market currently relies largely on brand self-regulation.

This makes consumer awareness all the more important. When shopping for intimate products in India, you cannot rely on a regulatory body to have pre-screened every product on the market. Instead, look for brands that voluntarily adhere to international standards and provide transparent information about their materials and certifications.

MyMuse's Material Standards

Every MyMuse intimate wellness product is made from platinum-grade, medical-grade silicone that meets international biocompatibility standards. Our silicone is phthalate-free, BPA-free, latex-free, and non-porous. We chose platinum-cured silicone not because it is the cheapest option — it is not — but because it is the safest option for products that are designed for intimate use.

In addition to our material standards, all MyMuse products are waterproof (making them easy to clean thoroughly), USB rechargeable (eliminating the need for battery compartments that can compromise waterproofing), and designed with both safety and pleasure in mind.

Frequently Asked Questions

Disclaimer: This article is for educational and informational purposes only. It is not intended as medical advice. If you have concerns about material sensitivities or allergies, please consult a qualified healthcare professional.

Written by the MyMuse Editorial Team

Last updated: February 2026