FDA Food Grade Silicone Gasket
Manufacturer & Custom Solutions
FDA Food Grade Silicone Gasket
ZSR Silicone FDA food grade gaskets meet 21 CFR 177.2600 for repeated food contact. They are non-toxic, odorless and handle pasteurization temperatures. Common applications include heat exchangers, mixing vessels and pasteurizer flanges.
FDA 21 CFR 177.2600
Rubber Articles Intended for Repeated Use
LFGB 30&31
EU Food Contact Materials
USP Class VI / ISO 10993
Biocompatibility of Medical Devices
RoHS / REACH
Environmental Compliance
UL 94
Flammability of Plastic Materials
FDA Food Grade Silicone Gasket Specifications
Every gasket is made to order. Here is what we can manufacture — send a drawing for anything outside this range.
| Item | Range / Options | Test Standard |
|---|---|---|
| Material | VMQ, platinum-cured HCR / HTV, LSR (FVMQ on request) | — |
| Hardness | 30 – 80 Shore A (customizable) | ASTM D2240 |
| Thickness | 0.5 – 25 mm (sheet die-cut) / by tool (molded) | ASTM D374 |
| Max Size | Up to 2000 mm outer diameter, any shape | — |
| Working Temp | -60°C to +230°C (special grades to +300°C) | — |
| Process | Die-cut (laser / water jet / steel rule), compression molded, LSR injection | — |
| Compliance | FDA 21 CFR 177.2600 (COA per batch), LFGB on request | Extraction test |
| Color | Translucent, white, red, blue, black, Pantone match | Colorimeter ΔE<1 |
| Standards | AS568, DIN 3869 / 7603 / 11851 / 32676, ISO 1127 / 2852, ASME B16.21 / B16.5, or custom drawing | — |
| MOQ | Die-cut from stock sheet: 100 pcs | Molded: 500 pcs | — |
| Lead Time | Prototype / sample: 2–5 days | Production: 7–15 days | — |
Custom FDA Gaskets: Two Ways We Make Them
Whether you need 100 flat gaskets this week or a molded profile in volume, both start with the same FDA-compliant compounds.
Custom Die Cut FDA Gaskets
Flat gaskets cut from food-grade silicone sheet stock — the fastest route from drawing to part, with no tooling cost.
- Laser, water-jet or steel-rule cutting, tolerance down to ±0.1 mm
- Any 2D geometry: rings, rectangles, custom outlines with bolt holes
- 0.5–25 mm thickness from stock; pressure-sensitive adhesive lamination available (3M / tesa)
- MOQ 100 pcs; samples in 1–3 days
Custom Molded FDA Gaskets
Three-dimensional gaskets — O-ring grooves, beveled edges, integrated shapes — produced in-house from tool design to final cure.
- In-house mold design & making, typically 3–7 days
- Compression molding for solid profiles; LSR injection for high-volume precision parts
- Platinum-cured compounds with post-curing for lowest extractables
- MOQ 500 pcs; DFM feedback included with every quote
Built to Your Exact Spec
Custom Silicone Gaskets Options
Six Silicone Grades, One Perfect Match
Every gasket starts with the right compound. Platinum-cured and peroxide-cured systems are available for all grades — we recommend platinum cure for food and medical contact.
| Grade | Hardness (Shore A) | Temperature | Compliance | Best For |
|---|---|---|---|---|
| Industrial VMQ | 30 – 80 | -60°C to +230°C | RoHS / REACH | General industrial sealing |
| FDA Food Grade | 30 – 70 | -60°C to +230°C | FDA 21 CFR 177.2600, LFGB | Food & beverage equipment |
| Medical Grade (Platinum) | 10 – 70 | -60°C to +230°C | USP Class VI / ISO 10993 | Medical devices & laboratory |
| High Temperature | 40 – 80 | up to +300°C | RoHS | Ovens, lighting, engine bays |
| Fluorosilicone (FVMQ) | 40 – 80 | -60°C to +200°C | RoHS | Fuel, oil & solvent exposure |
| LSR (Liquid Silicone) | 10 – 80 | -60°C to +230°C | FDA / medical grades | High-volume precision parts |
Built to Your Drawing, Down to 0.05 mm
Size, thickness, cross-section and geometry are fully custom. Send a drawing, a flange standard number, or a physical sample — we handle the rest.
| Item | Range / Options |
|---|---|
| Size Range | Built to your drawing; standard flange sizes DN10 – DN300 / NPS 1/2″ – 12″ (see standards table below) |
| Thickness | 0.5 – 10 mm sheet-cut; molded parts per drawing — common: 1.5 / 2 / 3 / 4.5 mm |
| Cross-Section | Flat / lip seal / custom profile |
| Custom Geometry | Bolt holes, slots, tabs, self-centering designs |
| Construction | Solid silicone / adhesive-backed / PTFE-laminated |
| Tolerance | Molded ±0.05 – 0.1 mm; die-cut ±0.2 mm |
Any Color Your Brand or Assembly Needs
We color-match silicone compounds to Pantone or RAL references, including translucent and transparent grades for visual inspection points.
Your Brand, Built Into the Part
Branding, part numbers and batch traceability — molded in, engraved or printed, without compromising the seal.
Four Processes, One Factory
Molding, cutting, injection and finishing under one roof — we match the process to your volume, geometry and tolerance target.
| Process | How It Works | Best For |
|---|---|---|
| Compression Molding | Pre-formed silicone pressed and cured in a heated mold | Medium volumes, large or thick gaskets |
| Die Cutting | Precision-cut from silicone sheet | Flat gaskets, fast turnaround |
| LSR Injection Molding | Liquid silicone injected into closed molds | High volumes, tight tolerances |
| Adhesive Backing | PSA tape laminated and die-cut to shape | Peel-and-stick assembly |
| Rapid Prototyping | Prototype tooling before production mold | Fit & function validation |
FDA Compliance Explained
FDA 21 CFR 177.2600 is the U.S. regulation for rubber articles intended for repeated use in contact with food. It is the key rule behind every food grade gasket we make. The regulation works in two ways:
1. It controls the recipe. Only ingredients on the FDA's permitted list can go into the compound — the base polymer, the fillers, the curing agents, and the pigments. A silicone that uses a non-listed additive does not comply, no matter how good the base material is.
2. It controls what comes out. The finished rubber must pass extraction tests that measure how much material could migrate into food:
Food Contact Type | Test Method | Limit (First 7 Hours) | Limit (Next 2 Hours) |
|---|---|---|---|
Aqueous (water-based) foods | Distilled water at reflux | ≤ 20 mg per square inch | ≤ 1 mg per square inch |
Fatty foods | n-Hexane at reflux | ≤ 175 mg per square inch | ≤ 4 mg per square inch |
One honest clarification
The FDA does not issue "certificates" for rubber. A gasket is FDA-compliant when its formula follows the regulation and its test results stay under the limits — and we provide the documentation to prove it.
How ZSR makes it safe
Our food grade compounds are platinum cured, which leaves almost no chemical by-products in the rubber. Every batch then goes through a post-curing oven cycle — hours of controlled heating that drives out any remaining volatiles. The result is a gasket that is odorless, tasteless, and stable from the first day of service.
The simple rule
If the gasket touches food, drinks, or food-contact surfaces — directly or indirectly — choose food grade. If it only seals air, dust, or machine parts, industrial grade does the same sealing job for less money. For medical or body contact, step up to medical grade instead.
Application Examples
Our FDA food grade silicone gaskets work across the whole food chain:
Food processing flanges
pipeline and equipment flange seals on mixing, cooking, and filling lines
Dairy Tri-Clamp seals
sanitary gaskets for milk, cheese, yogurt, and ice cream production
Mixing tanks and kettles
manway covers, lid seals, and agitator gaskets
Beverage dispensing
seals in coffee machines, juice dispensers, beer taps, and vending equipment
Commercial ovens and proofers
door seals and panel gaskets that handle baking heat day after day
Bottling and packaging machinery
filler valves, capping heads, and conveyor equipment seals
All available as cut gaskets, molded parts, or sanitary Tri-Clamp styles — in white, translucent, red, or custom colors.
Related Silicone Gaskets
| Image | Product | Type | Short Info | Action |
|---|---|---|---|---|
| DIN 3869 Silicone Sealing Ring | Standard & Size | DIN 3869 profile sealing rings in silicone for hydraulic ports, working from -60°C to +200°C. | View Details |
| AS568 Standard Silicone Gaskets | Standard & Size | AS568 standard-size silicone gaskets for groove-based sealing applications. | View Details |
| EN 1514-1 Silicone Gasket | Standard & Size | EN 1514-1 silicone flat gaskets for PN flanges, IBC and FF types, standard and custom sizes. | View Details |
| ISO 7483 Silicone Gasket | Standard & Size | Silicone gaskets to ISO 7483 for ISO 7005 flanges, made for international projects and tenders. | View Details |
| Custom Die Cut Silicone Gaskets | Standard & Size | Flat silicone gaskets cut to any shape from sheet stock. Precision cutting for exact fits. | View Details |
| ISO 1127 Silicone Gasket | Standard & Size | Sanitary silicone gaskets matched to ISO 1127 stainless steel tube sizes for food and pharma lines. | View Details |
|
| Custom Molded Silicone Gaskets | Standard & Size | Three-dimensional silicone gaskets made by compression or injection molding. For complex sealing shapes. | View Details |
| B16.21 Silicone Gasket | Standard & Size | ZSR makes silicone gaskets to ASME B16.21, ring type and full face type, for Class 150 to 2500 pipe flanges. | View Details |
| ISO 2852 Silicone Gasket | Standard & Size | ISO 2852 silicone clamp gaskets for food industry couplings, FDA grade, factory direct from ZSR. | View Details |
| Standard Flange Silicone Gaskets | Standard & Size | Silicone gaskets cut to fit pipe flanges. Matches ANSI, DIN and JIS bolt patterns. | View Details |
| B16.5 Silicone Gasket | Standard & Size | Silicone gaskets from ZSR sized to fit ASME B16.5 flanges, NPS 1/2 to 24 inch, Class 150 to 2500. | View Details |
| Tri-Clamp / Sanitary Silicone Gaskets | Standard & Size | Hygienic silicone gaskets for food and pharmaceutical pipe connections. CIP and SIP compatible. | View Details |
| DIN 7603 Silicone Sealing Ring | Standard & Size | Flat silicone sealing rings made to DIN 7603 for screw plugs, banjo bolts and threaded fittings. | View Details |
| Metric Size Silicone Gaskets | Standard & Size | Metric dimension silicone gaskets for international equipment standards. | View Details |
| DIN 2690 Silicone Gasket | Standard & Size | Silicone flat gaskets to DIN 2690 / EN 1514-1 dimensions for PN6 to PN40 flanges, food grade available. | View Details |
| DIN 2691 Silicone Gasket | Standard & Size | Silicone gaskets made to DIN 2691 for tongue and groove flanges PN10 to PN160, ideal for plant repair. | View Details |
| DIN 11851 Silicone Gasket | Standard & Size | Food grade silicone gaskets for DIN 11851 sanitary unions, DN10 to DN150, FDA material. | View Details |
| DIN 32676 Silicone Gasket | Standard & Size | DIN 32676 tri-clamp silicone gaskets, FDA food grade, full size range in stock at ZSR factory. | View Details |
|
| FDA Food Grade Silicone Gasket | Grade | Food-safe silicone gaskets for processing equipment. FDA-compliant and taste-neutral. | View Details |
| Medical Grade Silicone Gasket | Grade | Biocompatible silicone gaskets for medical devices. Sterilizable with full documentation. | View Details |
| Industrial Grade Silicone Gasket | Grade | General-purpose silicone gaskets for industrial sealing. Reliable, durable and cost-effective. | View Details |
| High Temperature / Heat Resistant Silicone Gaskets | Special Function | Heat-resistant silicone gaskets rated for continuous use above 200°C. For ovens and furnaces. | View Details |
| Solid Silicone Rubber Gaskets | Materials | Solid silicone rubber gaskets with excellent compression set resistance and long service life. | View Details |
| Fluorosilicone (FVMQ) Gaskets | Materials | Fuel and solvent-resistant silicone gaskets for chemical processing and automotive applications. | View Details |
| Transparent / Clear Silicone Gaskets | Color | Clear silicone gaskets for visible sealing and light-transmitting applications. | View Details |
| Black / White Silicone Gaskets | Color | Standard black and white silicone gaskets. Fastest delivery from stock. | View Details |
What Is FDA Food Grade Silicone?
FDA food grade silicone is a silicone rubber formulated and manufactured to be safe for repeated contact with food. Every ingredient in the compound — from the base polymer to the pigment — comes from the U.S. FDA's permitted list for food-contact rubber, and the finished material is tested to prove that nothing harmful migrates into food. It looks and feels like ordinary silicone, but behind it is a controlled recipe, a cleaner curing process, and documented proof of safety. It is the material the food industry trusts to seal what we eat and drink.
Key Properties of FDA Food Grade Silicone
FDA Gaskets for Every Stage of the Food Chain
The same compliant compound, tuned to each industry's cleaning cycle, temperature and certification needs.
Food & Beverage Processing
Flange seals for mixing, cooking and filling lines; dispensing valves for coffee, juice and beer equipment; oven and proofer door seals. CIP-washdown resistant and taste-neutral.
Dairy & Sanitary
Tri-Clamp (ISO 2852), DIN 11851 and ISO 1127 union gaskets for milk, yogurt and cheese lines. Steam-sterilizable, SIP/CIP compatible, full size range in stock.
Pharmaceutical & Bioprocessing
When USP Class VI / ISO 10993 biocompatibility is required, our medical grade gaskets add extractables documentation and sterilization validation on top of the same platinum-cured base.
How to Verify an FDA Gasket Supplier
"FDA approved" is a misuse — the FDA does not approve or certify rubber gaskets. A trustworthy supplier proves compliance with documents, not logos.
- Formula compliance statement — confirms every ingredient is on the FDA permitted list for rubber articles (21 CFR 177.2600), not just the base polymer.
- Extraction test results — distilled-water and n-hexane extraction values within the limits: ≤ 20 mg/in² (first 7 h, aqueous), ≤ 175 mg/in² (first 7 h, fatty food simulant).
- Certificate of Analysis (COA) — batch-level proof covering hardness, specific gravity and cure state. We provide a COA with every shipment.
- Traceability — compound lot numbers on every batch, so a gasket in service can be traced back to its raw materials.
- Curing system — prefer platinum-cured compounds with post-curing for food contact; they leave far fewer volatile residues than peroxide-cured rubber.
Our quality system is certified to ISO 9001:2015, and audit reports are available on request — see ZSR certifications. For a deeper look at silicone grades, read our silicone material guide.
FDA Food Grade Silicone Gasket FAQs
Quick answers to the questions buyers ask us most.