Custom rubber components molded, extruded, and die-cut from FDA-compliant and NSF-compliant materials, with dimensional tolerances tight enough for device-housing and fluid-path applications.
Hongjie Sealing Technology molds and extrudes rubber and silicone components for medical-device and healthcare-equipment OEMs. Production follows IATF 16949:2016 and ISO 13485:2016 certification, with statistical process control, defined acceptance criteria and documented change control supporting consistent part production.
The facility is semi-automated and not cleanroom-classified. It serves medical, automotive, appliance, hydraulic and general industrial OEMs through shared production capacity rather than operating a dedicated medical-only line.
This model can help control tooling costs and lead times, but component-level lot traceability, sterilization validation and Device Master Record documentation are outside Hongjie's scope. Material compliance documentation is provided, while device-level validation remains part of the OEM's quality system.
Medical and healthcare OEMs source the following molded, extruded, and die-cut rubber parts from us:
Device housings and instrument seals often use compression-molded silicone geometries. Medical silicone molded seals are produced in platinum-cured compounds and sized for sealed enclosures, probes and related assemblies.
Material selection depends on where the component sits in the device and what it contacts:
Suitable for skin-adjacent housings and diaphragms, with FDA-compliant low-odor formulations available.
Used for fluid-path seals exposed to aggressive reagents or sterilants.
Suitable for steam-exposed enclosures and water-contact components.
Used for general device housings, grommets and vibration mounts where material compliance is more important than extreme chemical resistance.
FDA- and NSF-compliant material documentation is available on request. Hongjie does not independently issue ISO 10993 biocompatibility or cytotoxicity test reports, so device-level biocompatibility qualification remains part of the OEM's testing program.
| Dimension Range | Standard Tolerance | Precision Tolerance |
|---|---|---|
| 0–10mm | ±0.10mm | ±0.02mm |
| 10–25mm | ±0.15mm | ±0.05mm |
| 25–50mm | ±0.20mm | ±0.08mm |
| 50–100mm | ±0.25mm | ±0.10mm |
Compounds are checked against 500+ fluids, gases, and chemicals for compatibility before parts ship. Functional prototypes come back in as little as 3–5 business days. Seal geometry is confirmed through 3D CAD modeling and FEA simulation, working directly from STEP or IGES files, before any tooling is cut.
Hongjie operates an 11,000 m² facility with roughly 150 employees and more than 3,500 existing production tools. The company has manufactured rubber components continuously since 2001.
This shared tooling library supports both catalog-based sizing and fully custom medical parts, using the same production resources as automotive and industrial programs. The model can reduce tooling costs and lead times, but Hongjie does not operate a dedicated medical-only production line.
Upload your drawing or spec for an OEM quote and our engineers will confirm material fit, tolerance, and prototype timing before tooling begins. We support projects from first sample through mass production, with the same compound and process carried through both stages.
Request a quote from our engineering team to start your project.
For food-contact, medical or high-temperature flat seals, silicone rubber gaskets cover the range EPDM and NBR cannot.
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