| Payment Terms | T/T, L/C, PayPal, Western Union |
| Supply Ability | 100000 Pieces per Month |
| Delivery Time | 25-35 working days for new mold, 7-15 days for production |
| Packaging Details | Export-grade carton with PE bag, palletized for container shipment |
| Material | Medical-grade LSR |
| Sterilization | EtO, Gamma, Autoclave |
| Brand Name | Creator |
| Model Number | KD-MED-SIL-001 |
| Place of Origin | Xiamen, Fujian, China |
| Certification | ISO 13485:2016 |
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Product Specification
| Payment Terms | T/T, L/C, PayPal, Western Union | Supply Ability | 100000 Pieces per Month |
| Delivery Time | 25-35 working days for new mold, 7-15 days for production | Packaging Details | Export-grade carton with PE bag, palletized for container shipment |
| Material | Medical-grade LSR | Sterilization | EtO, Gamma, Autoclave |
| Brand Name | Creator | Model Number | KD-MED-SIL-001 |
| Place of Origin | Xiamen, Fujian, China | Certification | ISO 13485:2016 |
| High Light | ISO 13485 Certified Injection Molding Service ,Biocompatible LSR Molding ,Sterilization-Compatible Medical Silicone Molding | ||
Xiamen Creator Technology Co., Ltd. provides ISO 13485 certified medical-grade silicone injection molding for surgical instrument handles, grips, and medical device components. Our liquid silicone rubber (LSR) molding process in an ISO Class 8 cleanroom ensures biocompatible, sterilizable components meeting the most stringent medical industry requirements.
| Certification | ISO 13485:2016, ISO 9001:2015 |
| Material | Medical-grade LSR, Solid Silicone, TPE |
| Cleanroom Class | ISO Class 8 (100,000) |
| Mold Material | S136 Stainless Steel, NAK80 |
| Mold Precision | ±0.01mm |
| Sterilization | EtO, Gamma, Autoclave Compatible |
| Durometer Range | 20 - 80 Shore A |
| Lead Time | 30-40 working days |
Our dedicated medical molding facility features an ISO Class 8 cleanroom with HEPA filtration and positive pressure control. We utilize advanced LSR injection molding machines with precise temperature and pressure control for consistent silicone part quality. Every production lot undergoes rigorous inspection and is accompanied by complete device history records including material certifications, process parameters, and final QC reports.
Q: Are your silicone materials medical grade?
A: Yes. We use medical-grade LSR and solid silicone materials that are biocompatible per ISO 10993 and suitable for surgical instrument applications.
Q: Can you produce overmolded surgical grips?
A: Yes. We offer LSR overmolding onto plastic or metal substrates for soft-touch surgical instrument handles with excellent chemical resistance.
Q: What sterilization methods are compatible?
A: Our silicone components are compatible with EtO gas, Gamma irradiation, and steam autoclave sterilization methods.
Q: Do you provide biocompatibility test reports?
A: We can provide material biocompatibility documentation from our raw material suppliers and coordinate additional testing through certified labs when needed.
Company Details
Business Type:
Manufacturer,Exporter,Trading Company,Seller
Year Established:
2007
Total Annual:
2000000-3000000
Employee Number:
40~50
Ecer Certification:
Verified Supplier
OEM Products manufacture for 12years, mainly focus on Plastic mold design and making, injection molding,assembly and packing. Xiamen Creator Technology has been providing the custom mold, injection molding and complete OEM products service since 2007. We work closely with our R&D engineers to i... OEM Products manufacture for 12years, mainly focus on Plastic mold design and making, injection molding,assembly and packing. Xiamen Creator Technology has been providing the custom mold, injection molding and complete OEM products service since 2007. We work closely with our R&D engineers to i...
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