Medical equipment silicone accessories, medical grade silicone, biocompatibility indicators, performance, manufacturer direct sales

I. Raw Material Description
The core raw material of silicone wiring harness adopts 70° fumed silica gel, a high-end silicone material dedicated to medical devices. It strictly complies with medical biosafety standards, fits the harsh service environments of medical consumables, and guarantees product quality and application safety from the source.
This material boasts multiple core advantages. Compared with ordinary silicone, fumed silica gel features higher purity and extremely low impurity content. It is odorless, non-toxic and harmless, with excellent biocompatibility. It can stay in long-term contact with human medical parts without triggering adverse reactions such as allergies or irritation.
The 70-degree hardness is a dedicated matching hardness for insulin pen accessories, balancing excellent flexibility and structural stability. It adapts to repeated plugging and opening/closing operations of insulin pens, resisting hardening, embrittlement and deformation, while ensuring precise sealing and fitting of accessories.
In addition, the raw material withstands high and low temperatures, aging and medicinal liquid corrosion. It can resist erosion from insulin medicinal liquids and daily disinfectants, without yellowing or performance degradation after long-term use, perfectly meeting the high-frequency and long-lasting service requirements of medical consumables.
II. Raw Material Performance Parameters

III. Production Process
The entire production of our products adopts the integrated molding process via fumed silica gel vulcanization, combined with standardized production in a dust-free workshop and full-inspection control procedures. This meets the high-precision and high-cleanliness production standards for medical devices, eliminating contamination and defects arising during production.
Supported by mature integrated vulcanization molding technology, the precisely proportioned Shore A 70 fumed silica gel raw materials are cured and shaped in one single step through constant-temperature and constant-pressure vulcanization. No secondary splicing or bonding is required, completely eliminating hidden risks such as gaps, detachment and liquid leakage inherent to traditional splicing processes. The finished products feature a dense, uniform overall structure, high dimensional accuracy and stable sealing performance, which effectively improve the fitting compatibility and service life of the accessories.
To satisfy the strict cleanliness requirements for medical devices, all procedures including production, molding, trimming and inspection are carried out in a professional dust-free workshop. The workshop rigorously controls pollution sources such as dust, microorganisms and impurities to ensure products meet cleanliness standards and avoid adhesion of bacteria and dust, complying with medical sterile and clean usage specifications.
After production, a 100% full inspection system is implemented before warehousing. Operators conduct one-by-one screening of each product against indicators including dimensional accuracy, surface flatness, sealing performance, flexibility and surface defects to reject non-conforming items. Strict outgoing quality control is enforced to guarantee all warehoused products comply with the quality standards for medical device accessories.

IV. Escenarios de Aplicación del Producto
El arnés de silicona es un accesorio central exclusivo para plumas de insulina y un componente complementario fundamental de las plumas inyectoras de insulina portátiles. Es compatible con una amplia gama de modelos convencionales de plumas de insulina para uso doméstico y clínico, y se emplea principalmente en las inyecciones subcutáneas de insulina para pacientes diabéticos.
Dentro de la pluma de insulina, este producto cumple funciones esenciales: sellado, conducción, ajuste hermético y amortiguación protectora. Se adapta con precisión a la estructura interna de montaje de la pluma, garantiza la estanqueidad interna del cuerpo del dispositivo y evita filtraciones y contaminación del líquido de insulina. Asimismo, responde de forma estable a los movimientos de presión y retroceso durante la inyección, asegura una dosis de inyección exacta y un flujo fluido del medicamento, y permite que la pluma de insulina realice operaciones de inyección estables y seguras.
Cubre una amplia variedad de escenarios de uso: es apto para el control glucémico autónomo y las inyecciones diarias de insulina de pacientes diabéticos en el hogar, además de adaptarse a entornos médicos profesionales como hospitales comunitarios, consultorios e instituciones sanitarias para inyecciones rutinarias de insulina en consultas y atención de enfermedades crónicas. Gracias a sus ventajas de alta limpieza, gran estabilidad y excelente compatibilidad, cumple plenamente las normativas de seguridad de materiales médicos desechables y resiste el uso repetido a largo plazo con alta frecuencia. Se trata de un accesorio de alta precisión e imprescindible para la seguridad de las plumas de insulina.