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Building 4, Huaqiang Ecology and Technology Park, Guangming District, Shenzhen, Guangdong, China

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Medical Seals



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Medical & Life Science

Medical Seals

FDA-Registered Medical Seals for Sterile & Reusable Device Applications

THOR-SOFT is an FDA-registered manufacturer of medical-grade silicone seals designed for sterile environments and reusable medical devices. Our seals meet stringent USP Class VI, ISO 10993, and ISO 13485 requirements — ensuring patient safety in surgical instruments, diagnostic equipment, and pharmaceutical processing.

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TECHNICAL SPECIFICATIONS

Product Details & Parameters

Material Medical-grade LSR / Platinum-cure silicone Biocompatibility USP Class VI, ISO 10993-5 cytotoxicity free
Sterilization Autoclave, ETO, Gamma, E-beam compatible Color Medical white, translucent, or custom color-coded
Size Range OD 3mm – 250mm, cross-section custom MOQ 100 pieces (prototypes from 10 pcs)
Certification ISO 13485:2016, FDA registration #pending Lead Time 10–18 working days



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WHY CHOOSE THOR-SOFT

Medical Seals Advantages

USP Class VI Safe
Cytotoxicity-free, non-sensitizing
Multi-Sterilizable
Compatible with all common methods
Clean Room Made
ISO Class 8 controlled environment
Traceability
Full batch traceability & COA provided



★★★★★
Trusted by 500+ Global Clients
“Medical Seals from THOR-SOFT consistently exceeds our quality expectations. Fast response, competitive pricing, and zero-defect delivery.”
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PRODUCT SHOWCASE

Medical Seals Gallery

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Showcase Image 1
Close-up View
Premium Quality Close-Up
Detailed view of finished medical seals
📷
Showcase Image 2
Application Scene
In-Use Application Shot
Real-world medical seals deployment
🏠
Manufacturing
Process Photo
Factory Production Line
Our manufacturing facility producing medical seals



APPLICATIONS

Where Medical Seals Are Used

Surgical instrument seals
syringe plungers
IV connector gaskets
endoscope seals
ventilator components
drug delivery devices
dialysis machine parts
orthopedic device seals



OUR MANUFACTURING

THOR-SOFT Production Process

1
Design Review
DFM analysis & optimization
2
Mold Making
Precision CNC tooling
3
Production
Injection/compression molding
4
QC Testing
Dimensional & visual inspection



FAQ

Frequently Asked Questions about {p[‘name’]}

What is the minimum order quantity (MOQ)?
We accept low-volume prototype orders starting from as few as 10-100 pieces for evaluation purposes. Standard production MOQ varies by product complexity — typically between 200-2,000 pieces.
Can you customize the material hardness and color?
Yes! We offer full customization of material hardness (Shore A 10-90), color (unlimited Pantone matching), and special additives like conductive fillers, radiopaque agents, or antimicrobial treatments.
How long does it take to receive my first samples?
For existing molds: 5-7 working days. For new tooling projects: 15-25 days (includes mold fabrication). Rush prototyping service available at additional cost.
Do you provide test reports and certifications?
Absolutely. Every shipment includes a Certificate of Analysis (COA) and Certificate of Conformance (COC). We can also arrange third-party testing (SGS, Intertek) and provide full material certification dossiers.



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