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FDA silicone parts
LIXU
As a professional FDA silicone rubber parts factory with 15+ years of expertise, we know safety and compliance are non-negotiable for your critical applications. Every batch of our FDA approved silicone rubber parts is engineered and produced in our ISO 9001-certified workshop, using 100% virgin food-grade silicone raw materials. Strictly adhering to FDA 21 CFR 177.2600 standards, our factory’s silicone components deliver unmatched performance for food processing, medical devices, pharmaceuticals, and household appliances. Whether you need standard parts or custom solutions, we cut out middlemen to offer factory-direct quality and pricing that meets your strictest requirements.
Heat Resistance: Our factory-tested silicone withstands -60°C (-76°F) to 230°C (446°F), ideal for oven gaskets, microwave components, and industrial machinery seals—we verify this in our high-temperature aging test chamber for every new formulation.
Chemical Resistance: Resists acids, alkalis, oils, and most solvents—our lab conducts immersion tests to ensure longevity in pharmaceutical processing and industrial environments, a standard we enforce for all factory production.
Flexibility & Durability: Maintains elasticity after 10,000+ use cycles (tested in-house), reducing your replacement costs and downtime. Our precision molding equipment ensures consistent thickness and structure for every part off the production line.
Hygienic & Easy to Clean: Non-porous surface (verified by our lab) prevents bacteria/mold growth—critical for food and medical industries. We design parts with smooth edges to meet strict hygiene standards, a detail our factory’s tooling team prioritizes.
| Performance Indicator | Specification | Test Standard | Factory Test Result |
|---|---|---|---|
| Temperature Resistance Range | -60°C (-76°F) to 230°C (446°F) | ASTM D1418 | Stable after 500h at 230°C |
| Shore Hardness | 30A to 80A (Customizable) | ASTM D2240 | ±2A tolerance per batch |
| Tensile Strength | ≥ 7.0 MPa | ASTM D412 | Average 7.8 MPa |
| Elongation at Break | ≥ 300% | ASTM D412 | Average 350% |
| Compression Set (22h/150°C) | ≤ 15% | ASTM D395 | 12% average |
| FDA Compliance | Meets FDA 21 CFR 177.2600 | FDA Guidelines | Passed heavy metal & BPA tests |
| Chemical Resistance | Resists acids, alkalis, oils | ASTM D1308 | No degradation after 72h immersion |
| Flammability Rating | UL94 V-0 | UL Standard | Passed vertical burn test |
FDA Silicone Gaskets & Seals
Food Grade Silicone O-Rings
Medical Silicone Tubing & Hoses
Silicone Rubber Mats & Pads
Custom Silicone Molded Components
Silicone Diaphragms for Valves
High-Temperature Silicone Spacers
Factory Quality Assurance: Our FDA silicone parts hold SGS, ISO 9001, and FDA certifications—we issue factory-direct test reports and compliance documents for every order, no third-party intermediaries.
Q1: Are your silicone rubber parts truly FDA approved?
A1: Yes—our factory only uses FDA-certified raw materials, and every batch passes FDA 21 CFR 177.2600 testing in our in-house lab. We provide factory-issued FDA certificates and test reports for every order.
Q2: Can you produce custom silicone parts according to my drawings?
A2: Absolutely. Our factory’s engineering team works directly with production to turn your 2D/3D drawings or samples into parts—we optimize tooling and processes for your needs, with prototypes ready in 3-7 days.
Q3: What is the lead time for custom FDA silicone parts?
A3: As the factory, we control production schedules—prototypes take 3-7 days, mass production 10-15 days. We offer expedited services for urgent orders, with direct communication to update you on progress.
Q4: Do your silicone parts resist high temperatures and chemicals?
A4: Yes—our factory tests every formulation to ensure -60°C to 230°C resistance and stability in acids, alkalis, and oils. We can provide lab test data to prove performance for your specific application.
