FDA Title 21 CFR 177.2600 Silicones
FDA Title 21 CFR 177.2600 silicones meet U.S. Food and Drug Administration (FDA) requirements for rubber articles intended for repeated use in contact with food. These requirements do not explicitly regulate medical devices. However, FDA Title 21 CFR 177.2600 establishes standards for material purity and low levels of extractables that are used for material selection in medical applications.
ElastaPro is a Made in USA manufacturer of FDA CFR 177.2600 silicones. We offer these materials as solid silicone sheets, continuous rolls, and uncured compound. Our medical grade silicones also meet USP Class VI, ISO 10993, and European Pharmacopoeia requirements. Contact us to request a quote or discuss your medical device or equipment application.
FDA Silicone Sheet
ElastaPro calendars FDA silicones into medical silicone sheeting that can be die cut into parts for peristaltic pumps, insulin pumps, and other types of medical devices and equipment. This process creates flexible, durable silicone sheets that can be precisely controlled for thickness, texture, and other properties.
FDA solid silicone sheet is available in:
- Durometers: 10 to 70 Shore A
- Thicknesses: .007” to .500”
- Widths: Up to 60”
- Colors: While typically translucent, various colors are availabe
These products are Made to Order and supplied in a gloss or matte finish.
FDA Continuous Rolls
ElastaPro can also supply you with FDA silicone rolls that we can slit-to-width for automated cutting operations.
FDA Uncured Silicone Compound
In addition to medical grade silicone sheets, ElastaPro offers uncured silicone compound that arrives ready-to-mold. Our materials are supplied rolled-up off the mill or in sheet form with a poly liner.
What is FDA Title 21 CFR 177.2600?
FDA Title 21 CFR 177.2600 is a U.S. regulation that’s designed to ensure harmful substances do not migrate into food or beverages during processing, packaging, or storage. It applies to rubber articles intended or repeated use in contact with food. However, FDA Title 21 CFR 177.2600 is frequently used by medical manufacturers as a basic benchmark.
It’s important to note that compliance with 21 CFR 177.2600 alone does not guarantee that a material is approved for all medical uses. As a regulatory agency, the FDA evaluates medical devices and equipment in their entirety, and not just individual component materials. That’s why medical grade silicones may also need to meet USP Class VI and ISO 10993 requirements.
FAQs for for FDA Title 21 CFR 177.2600 Silicones
What is FDA Title 21 CFR 177.2600 and why does it matter for silicone materials?
FDA Title 21 CFR 177.2600 is the U.S. regulation that defines which rubber articles—including silicone—are permitted for repeated food‑contact applications. Materials must meet strict extractables limits when exposed to water and n‑hexane, ensuring they do not transfer harmful substances into food.
What types of silicone products can comply with FDA 21 CFR 177.2600?
Silicone sheet, silicone rolls, and uncured silicone compounds can all be formulated to meet FDA 21 CFR 177.2600 requirements. ElastaPro manufactures platinum‑cured and peroxide‑cured options depending on the application, purity needs, and processing method.
What testing is required for FDA 21 CFR 177.2600 compliance?
Compliance requires extractables testing in both water and n‑hexane under defined time and temperature conditions. The material must remain below the allowable extractable limits to qualify for repeated food‑contact use.
Are ElastaPro’s FDA‑compliant silicones platinum‑cured or peroxide‑cured?
Both options are available. Platinum‑cured silicones offer the lowest extractables and highest purity, while peroxide‑cured silicones provide excellent mechanical strength and cost‑effective performance for many food‑processing environments.
What temperature range can FDA 21 CFR 177.2600 silicone withstand?
ElastaPro’s FDA‑compliant silicones typically operate from −80°F to +450°F, with intermittent resistance up to 500°F. This makes them suitable for ovens, freezers, food‑processing equipment, and thermal cycling environments.
What applications commonly use FDA 21 CFR 177.2600 silicone?
Typical uses include food‑processing gaskets, oven seals, conveyor belting, beverage equipment, dairy processing, sanitary seals, and any application requiring repeated food contact and low extractables.
What sizes, durometers, and thicknesses are available?
ElastaPro produces FDA‑compliant silicone in durometers from 10–80 Shore A, widths up to 60 inches, and thicknesses from 0.007 to 0.500 inches. Custom dimensions and formulations are available for specialized food‑processing requirements.
Does FDA 21 CFR 177.2600 compliance guarantee suitability for medical applications?
No. FDA 21 CFR 177.2600 addresses food‑contact safety, not medical biocompatibility. For medical or pharmaceutical applications, materials should meet USP Class VI, ISO 10993, or European Pharmacopoeia standards.
Can ElastaPro provide documentation for regulatory compliance?
Yes. ElastaPro provides a Declaration of Compliance (DoC) confirming that the silicone formulation has passed FDA 21 CFR 177.2600 extractables testing and is suitable for repeated food‑contact use.
Ask ElastaPro for FDA Title 21 CFR 177.2600 Silicones
Do you need FDA Title 21 CFR 177.2600 silicones? Contact ElastaPro for specifications grade solid silicone sheets, continuous rolls, and ready-to-mold compounds. Our medical grade elastomers meet FDA Title 21 CFR 177.2600, and they also comply with USP Class VI, ISO 10993, and European Pharmacopeia standards.
