FDA 21 CFR 177.2600 Silicones
ElastaPro is a Made in USA manufacturer of FDA 21 CFR 177.2600 solid silicone sheet and uncured silicone compound. These high-purity elastomers meet U.S. Food and Drug Administration (FDA) requirements for rubber articles intended for repeated use in contact with food. While this regulation establishes critical standards for material purity and low extractable levels, our medical grade silicones also meet USP Class VI, ISO 10993, and European Pharmacopoeia requirements.
FDA Silicone Product Forms
ElastaPro supplies FDA 21 CFR 177.2600 compliant materials in three primary forms:
1. FDA Solid Silicone Sheet
ElastaPro calenders FDA silicones into high-precision medical silicone sheeting. These durable, flexible sheets can be die-cut into custom parts such as gaskets and diaphragms for peristaltic pumps, insulin pumps, and processing equipment.
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Durometers: 10 to 80 Shore A
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Thicknesses: 0.007” to 0.500”
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Widths: Up to 60”
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Colors: Translucent (standard); custom colors available
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Finishes: Gloss or matte (Made to Order)
2. FDA Continuous Silicone Rolls
For automated cutting operations and high-volume converted parts, ElastaPro manufactures FDA silicone rolls that can be slit-to-width.
3. FDA Uncured Silicone Compound
For custom molding operations, ElastaPro offers ready-to-mold uncured silicone compound. Materials are supplied rolled-up off the mill or in sheet form with a protective poly liner.
Material Capabilities & Curing Options
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Cure Systems: Available in both platinum-cured (ultra-low extractables, maximum purity) and peroxide-cured (cost-effective, high mechanical strength) formulations.
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Temperature Resistance: Typically operates from −80°F to +450°F, with intermittent thermal resistance up to 500°F.
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Applications: Food-processing gaskets, oven seals, conveyor belting, beverage equipment, dairy processing, sanitary seals, and medical equipment components.
What is FDA Title 21 CFR 177.2600?
FDA Title 21 CFR 177.2600 is a U.S. federal regulation designed to ensure that harmful substances do not migrate into food or beverages during processing, packaging, or storage. It defines allowable ingredients and strict extractable limits under defined time and temperature conditions when exposed to water and n-hexane.
Although created for repeated food-contact applications, medical manufacturers frequently use 21 CFR 177.2600 as a baseline benchmark for material cleanliness.
FDA Approved vs. FDA Compliant: Key Differences
Understanding the regulatory distinction between “FDA Approved” and “FDA Compliant” is essential for proper specification in food processing and medical manufacturing:
| Feature | FDA Compliant | FDA Approved |
| Scope |
Applies to raw materials & components (e.g., silicone sheeting, compounds). |
Applies to finished end-use products or devices (e.g., a specific medical device or drug). |
| Mechanism |
Formulated using approved ingredients and tested against extractable limits (such as 21 CFR 177.2600). |
Evaluated directly by the FDA through formal submittal processes (510(k), PMA, etc.). |
| Agency Role |
The FDA does not pre-approve raw raw-materials; manufacturers self-certify or issue a Declaration of Compliance (DoC). |
The FDA explicitly reviews and approves the full finished assembly for market entry. |
Note: Compliance with 21 CFR 177.2600 alone does not guarantee suitability or approval for all medical uses. The FDA evaluates medical devices and equipment as complete assemblies. For medical device applications, materials often require additional testing to satisfy standards like USP Class VI and ISO 10993.
Frequently Asked Questions (FAQ) about FDA 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 defining rubber articles—including silicone—permitted for repeated food-contact applications. Materials must meet strict extractables limits when exposed to water and n-hexane to ensure safety.
What types of silicone products can comply with FDA 21 CFR 177.2600?
Silicone sheets, continuous rolls, and uncured compounds can all be formulated to meet 21 CFR 177.2600 requirements.
What testing is required for FDA 21 CFR 177.2600 compliance?
Compliance requires extractables testing in both distilled water and n-hexane under defined time and temperature conditions to confirm migration levels remain within regulatory limits.
Are ElastaPro’s FDA-compliant silicones platinum-cured or peroxide-cured?
Both options are available. Platinum-cured silicones offer lower extractables and higher purity, while peroxide-cured silicones offer excellent mechanical performance for standard food-processing environments.
What temperature range can FDA 21 CFR 177.2600 silicone withstand?
Operating temperatures range from −80°F to +450°F (−62°C to +232°C), with intermittent heat resistance up to 500°F (260°C).
What applications commonly use FDA 21 CFR 177.2600 silicone?
Common uses include food-processing gaskets, oven seals, sanitary seals, conveyor belting, beverage dispensers, dairy processing, and low-extractable medical device components.
What sizes, durometers, and thicknesses are available?
ElastaPro manufactures FDA-compliant silicones in durometers from 10 to 80 Shore A, widths up to 60 inches, and thicknesses from 0.007 to 0.500 inches.
Does FDA 21 CFR 177.2600 compliance guarantee suitability for medical applications?
No. 21 CFR 177.2600 regulates food contact, not medical biocompatibility. For medical or pharmaceutical applications, materials should also 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) certifying that the silicone formulation meets FDA 21 CFR 177.2600 extractable limits.
