Fluid & Respiratory
Tubing, catheters, respiratory and anesthesia masks.
View medical applicationsSilicone Medical & Healthcare Products Manufacturer
Custom medical-grade silicone components — tubing, respiratory masks, seals, valves and wound care parts molded in a cleanroom environment with documented material and inspection control.
For Medical & Healthcare Brands
Medical-Grade Silicone You Can Trust
Medical and healthcare products demand more than good molding. They need documented materials, clean production, tight tolerances and traceable inspection.
We manufacture tubing, catheters, respiratory and anesthesia masks, wound care components, syringe and valve parts. Each project is reviewed for biocompatibility, cleanroom class and your target market's regulatory documentation.
Product Range
Popular Silicone Medical Products
These are application examples, not fixed stock items. Each product can be reviewed for custom design and branding.
Seals & Valves
Wound care parts, seals, gaskets and valve components.
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Device Components
Syringe parts, connectors and precision-molded inserts.
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Medical Product Project Checklist
| Requirement | Questions to answer | What it helps define |
|---|---|---|
| Material & biocompatibility | Does the product contact tissue, fluid or breatheable air? | Material grade and regulatory documentation |
| Cleanroom class | Is ISO Class 7 or higher required for the molding environment? | Production environment and process validation |
| Tolerance & finish | What dimensional and surface requirements apply? | Mold design and inspection criteria |
| Destination market | Which regulatory body (FDA, CE, MDR) applies? | Documentation, testing and compliance plan |
| Sterilization | Will the part be sterilized, and by what method? | Material selection and design for sterilization |
Documentation & Compliance
The Evidence Behind the Label
A compliance mark alone does not tell you what a material is actually approved for. Here is what we provide — and, just as importantly, what we do not claim — so you can build a defensible documentation package for your market.
| Requirement | Material / test evidence we provide | What it covers (and does not cover) |
|---|---|---|
| Food-contact safety | FDA 21 CFR 177.2600 & LFGB material compliance certificates | Confirms the silicone compound meets food-contact requirements. It is a material-level statement, not a product "approval". |
| Biocompatibility | USP Class VI / ISO 10993 test reports (where applicable) | Applies to specific materials and contact scenarios. Each device's final biocompatibility is the buyer's responsibility under its own regulatory filing. |
| Material traceability | Batch-level material certificates and lot numbers | Links every production lot back to its raw silicone batch and machine parameters. |
| Dimensional & mechanical | Inspection reports: dimensional, hardness (Shore A), tensile & elongation | Verifies the finished part meets the agreed specification, per batch. |
| Restricted substances | RoHS / REACH third-party test reports | Covers the specific compound and product scope tested, not the entire catalog. |
| Cleanroom environment | ISO Class 7 (ISO 14644-1:2015) cleanroom, certificate CR-2026-0714 | LSR medical molding & packing area, verified by an independent third-party cleanroom testing laboratory. We still do not claim an ISO 13485 certificate unless one is held and in scope for your product. |
Medical devices carry their own regulatory obligations. We manufacture to your specification and provide the material, inspection and traceability evidence — the device-level certification and market approval remain with the buyer and its notified body or agency.
Medical LSR Components
Liquid Silicone for Medical & Healthcare Devices
Liquid silicone rubber (LSR) injection is the process of choice for high-precision, high-purity medical components — fine-detail seals, valves, diaphragms and gaskets molded in a cleanroom with repeatable part-to-part control.
Medical Silicone Seals & Diaphragms
LSR-injected seals and diaphragms with ±0.02 mm critical-dimension tolerance and documented process capability.
Cleanroom LSR Molding
Medical LSR molding and packing in an ISO Class 7 cleanroom, with cold-runner systems for high-purity, low-waste production.
Validated to Production
From first-article inspection through EVT/DVT/PVT validation to PPAP documentation — the full engineering chain for medical programs.
Explore the engineering behind medical components: EVT / DVT / PVT validation · PPAP & quality documentation · LSR components.
OEM / ODM Customization
Build the Product Around Your Brand
- Custom shape, dimensions and hardness
- Pantone color matching and multi-color designs
- Embossed, debossed or printed branding
- Private-label and retail packaging
- Pre-production samples for approval
Common Questions
Medical Product Manufacturing FAQ
Yes. We produce medical and healthcare silicone parts with food-grade and medical-grade materials, cleanroom molding where required, and documented inspection. Material, tolerance and any regulatory documentation are agreed with you for the specific device and market.
We work with medical-grade materials and run our LSR medical molding and packing area in an ISO Class 7 cleanroom (ISO 14644-1:2015, certificate CR-2026-0714) verified by an independent third-party cleanroom testing laboratory. For specific regulatory certificates applicable to your product, contact us to confirm the documentation we can provide for your market.
Depending on the project, we can provide material certificates (FDA, USP Class VI, ISO 10993 where applicable), inspection reports and traceability records. The exact documentation package is confirmed against your device and target market requirements.
Planning a Silicone Medical or Healthcare Product?
Send your product reference, intended use and destination market so we can begin with the right questions.
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