The difference between medical grade and food grade LSR (Liquid Silicone Rubber) silicone primarily lies in their purity, safety standards, and intended applications.
1, Purity & Additives
Medical Grade LSR silicone:
Extremely high purity.
Contains no harmful additives, fillers, or plasticizers.
Designed to be biocompatible—safe for contact with human tissues, blood, and bodily fluids.
Often platinum-cured (for higher purity and stability).
Food Grade LSR silicone:
High purity, but less stringent than medical grade.
Safe for contact with food and beverages.
Also platinum-cured, but minor differences in allowable ingredients may exist.
2,Regulatory Standards
Medical Grade LSR silicone:
Must pass ISO 10993, USP Class VI, or FDA Class II/III certifications depending on application.
Suitable for use in implants, catheters, wound care, etc.
Often tested for cytotoxicity, sensitization, and systemic toxicity.
Food Grade LSR silicone:
Must meet FDA 21 CFR 177.2600 or equivalent for food contact.
Safe for kitchenware, baby products, etc.
Less rigorous testing than medical-grade materials.
3, Applications
Surgical tools, respiratory masks, implants, seals for medical devices.
Long-term human contact, internal or external.
Baking molds, baby bottle nipples, spatulas, seals for food containers.
Short-term contact with food or human skin.
4, Cost
Medical grade silicone is generally more expensive due to higher processing standards and more stringent testing.
| Property | Medical Grade LSR | Food Grade LSR |
|---|---|---|
| Purity | Ultra-high | High |
| Biocompatibility | Required | Not required |
| Regulatory Standards | ISO 10993, USP Class VI | FDA 21 CFR 177.2600 |
| Applications | Medical devices, implants | Cookware, baby items |
| Cost | Higher | Lower |
Liquid Silicone Rubber (LSR) has become a critical material across various industries due to its durability, flexibility, chemical resistance, and ability to withstand extreme temperatures. Its applications range from kitchen tools and baby products to surgical implants and drug delivery systems. And medical grade and food grade lsr silicone—serve distinct purposes and are subject to different manufacturing standards, regulatory approvals, and performance requirements.
Let’s discuss if you want help choosing one for a specific product or application.
