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Medical Device Silicone Knob Medical Grade Silicone Biocompatibility Index Energy Head Factory

Color: grey,white,Red, Yellow, Green,etc
Material: 100% pure food grade silicone
Sales Models: Wholesale
Min Order: 10pcs
Availability:
Quantity:
  • Medical Device Silicone Knob

  • qiniu

I. Raw Material Specification
The silicone knob products are manufactured using 50 Shore pure medical-grade silicone raw materials, with no recycled secondary materials or adulterated auxiliary ingredients. The raw materials meet the industry standards for medical device production, serving as high-end silicone substrates suitable for medical scenarios.
The 50 Shore medical-grade silicone features moderate hardness, balancing flexibility and structural stability, with excellent medical compatibility and safety performance. The raw material itself is non-toxic, odorless, non-sensitizing, and free of harmful substance precipitation. It has passed biocompatibility testing, allowing direct contact with human skin, mucous membranes and medical liquid medicines without causing corrosion or contamination. Meanwhile, the material boasts outstanding resistance to high and low temperatures, aging, and acids & alkalis. It can undergo repeated high-temperature sterilization and disinfection cleaning, resisting deformation, cracking and yellowing, and maintains stable physical properties and appearance during long-term service.
Compared with ordinary industrial silicone, medical-grade silicone delivers higher purity and far fewer impurities, along with superior air tightness, anti-slip performance and tactile texture. It fully satisfies the stringent requirements of medical devices for supporting parts in high precision, high safety and high durability.
II. Raw Material Performance Parameters

Routine Test Item Test Standard YH-7151
Color Visual Inspection Blue, Grey
Density (g/cm³) GB/T16583-1996 1.28
Hardness (Shore A) GB/T531.1-2008 50±3
Tensile Strength (MPa, Min.) GB/T 528-2009 8.0
Elongation at Break (%, Min.) GB/T 528-2009 320
Permanent Set at Break (%, Max.) GB/T 528-2009 6
Tear Strength (kN/m, Min.) GB/T 529-2008 20
Compliant with RoHS and REACH standards

III. Production Process
We specialize in custom processing of silicone products for medical devices, adopting standardized and refined production procedures throughout manufacturing. Relying on integrated compression molding technology with vulcanizing machines, combined with a quality inspection system in dust-free workshops, we control product precision and yield rate from the source to meet high-quality supply demands in the medical industry.
1.Raw Material Pretreatment
The incoming 50-Shore medical-grade silicone raw materials undergo screening, refining and degassing to eliminate internal bubbles and impurities inside the materials. This ensures material uniformity and lays a foundation for high-precision molding of finished products, completely avoiding defects such as air holes, blemishes and uneven stress distribution in finished goods.
2.Precise Mold Alignment
High-precision steel molds are custom-made according to customized dimensions and structural parameters of medical device accessories and silicone knobs. Mold precision is controlled within an extremely narrow tolerance range of the industry, guaranteeing consistent and uniform dimensions, arcs, slots and textures for every product, which matches assembly standards of all types of medical equipment.
3.Integrated Compression Molding via Vulcanizing Machine
Fully automatic vulcanizing machines perform high-temperature and high-pressure compression molding, completing the full cycle of product shaping and vulcanization curing in one step without secondary splicing or secondary processing. The integrated molding process delivers compact product structures with uniform density and excellent overall flexibility that resists breakage. It effectively improves the product’s sealing performance, anti-slip property and assembly tightness, thoroughly eliminating drawbacks of spliced products such as loose fit, gaps and poor durability.
4.Refined Post-treatment
Molded products go through edge trimming, deburring and flattening polishing. All edges and corners are smooth without sharp edges, and surfaces are delicate and defect-free to satisfy precision assembly requirements of medical equipment while delivering comfortable hand feel during use.
5.Full Inspection Procedure in Dust-free Workshop
All finished products undergo full inspection in dust-free clean workshops, differing from conventional sampling inspection with 100% full screening. Quality inspectors test core indicators one by one, including dimensional accuracy, surface blemishes, air tightness, flatness, hardness and flexibility. Defective and substandard products are strictly rejected to prevent contaminated, dusty or flawed goods from entering the market, ensuring all delivered products fully meet cleanliness, safety and precision standards for medical device applications.
无尘车间全检硅胶圈 (6)

IV. Product Application Scenarios
Featuring safety, high precision, disinfection resistance and excellent compatibility, the medical silicone knob accessories are widely applicable to various medical equipment, medical devices and auxiliary medical apparatus. Their core application fields are listed below:
1.Medical Diagnosis & Treatment Equipment
Compatible with standard clinical devices including patient monitors, ventilators, anesthesia machines, infusion pumps, syringe pumps, physical therapy instruments and rehabilitation therapeutic equipment. They serve as adjustment knobs, sealing components, anti-slip protective fittings and control keys, precisely fulfilling equipment adjustment, sealing and protection functions while withstanding frequent operation and repeated disinfection cycles.
2.Precision Medical Instruments
Applied to minimally invasive surgical instruments, medical testing analyzers, medical calibration equipment, dental treatment devices, ophthalmic instruments and other precision medical appliances as miniature silicone fittings, adjustment knobs, sealing gaskets and shock-absorbing protective parts. Their high precision and ultra-clean quality meet strict assembly and service requirements for precision medical devices.
3.Medical Care & Rehabilitation Equipment
Suitable for hospital bed adjustment components, rehabilitation training gear, household medical physiotherapy equipment and elderly care devices. Silicone knobs enable gear shifting, tension control and angle adjustment of equipment; silicone protective and sealing accessories guarantee safe and stable equipment operation.
4.Laboratory Medical Equipment
Deployed on medical testing apparatus, lab analytical instruments and sample storage auxiliary devices. Leveraging the clean properties of medical-grade silicone, the products prevent contamination and interference to lab specimens and test data, fitting sterile, dust-free laboratory working environments.
5.General Supporting Medical Scenarios
All medical equipment supporting scenarios requiring sterility, disinfection resistance, superior sealing and anti-slip performance. Customization of dimensions, hardness and surface textures is available to satisfy personalized supporting demands for medical devices of diverse models and specifications.

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