Medical Silicone Components
A medical or healthcare-adjacent component such as a mask cushion, valve, septum or wearable soft part is a molded article. Grade identification, contact duration and the legal manufacturer's regulatory file belong with the device or parts OEM. Project acceptance depends on whether the requested manufacturing and documentation scope can be met.
Send the drawing or sample, intended use, material requirements and expected quantity. RUUIPON will review the manufacturing route, tooling scope and inspection needs before confirming the quotation.
Common mix-up
"Medical grade" without a named compound, contact type, and test list is a slogan. 21 CFR 177.2600 is extraction of an *article*, not a factory stamp. RUUIPON will not pretend a gummy-tray platinum report is a device file.
Typical shop values
| Object | Who quotes | What the RFQ must name |
|---|---|---|
| RTV cavity | RUUIPON | pour, grams, food-doc path on the *mold* if food-contact |
| Device-adjacent *part* | HTV product RFQ here, or ask us | grade, contact/duration, sterile intent, CTQs, legal-manufacturer tests |
Reference values only. Confirm material-specific limits against the supplier’s technical data and agree project acceptance criteria before production. A manufacturing shop is not automatically the regulatory owner of a medical device.
Quoted as a molded silicone article
This page quotes a molded silicone article, not an RTV casting cavity. We would not recommend pasting a gummy-tray 177.2600 report onto a patient-contact part. We would not recommend treating RUUIPON as a medical OEM catalog.
Path: RTV mold vs finished part
- What ships? - device-adjacent silicone part -> HTV product or mold RFQ
- Stay on RUUIPON: /contact/ -> MOQ 20 / $50 CAD when in scope / 3-7 days after CAD lock
- HTV product or mold RFQ -> MOQ, tooling cost and lead time are confirmed for the selected process, design and production quantity. RTV casting-mold terms do not apply automatically to finished silicone products. This page does not claim an FDA-approved factory.
Where to send the RFQ
Parts: device model, contact type/duration, STEP, three CTQs - send an HTV product RFQ here.
Molds: contact.
Send the drawing or sample, intended use, material requirements and expected quantity. RUUIPON will review the manufacturing route, tooling scope and inspection needs before confirming the quotation.
FAQ
Does RUUIPON make medical silicone parts? HCR medical-adjacent parts can be an HTV product RFQ. Device files stay with the legal manufacturer. Parts: send an HTV product RFQ here.
Is 21 CFR 177.2600 an FDA factory approval? No. It is extraction of a finished article. Don't treat it as a device clearance.
What information is needed for a medical-use component review? Send the component drawing, intended use, contact type and duration, material specification, destination market, and required quality and validation documentation. Project acceptance depends on whether the requested manufacturing and documentation scope can be met.
Mold MOQ here? 20 per design; $50 modeling when in scope; 3-7 days after CAD lock. Those are mold numbers only.
What if I need a mold to cast a medical-training model in resin? That *cavity* can be a RUUIPON RTV job. The molded silicone device still goes as an HTV product RFQ here, or ask us for a high-volume LSR tool.