FDA Compliant Custom Silicone Medical Components - Precision-Engineered for Medical Devices, Instrument Parts, Gaskets & Tubing

FDA Compliant Custom Silicone Medical Components - Precision-Engineered for Medical Devices, Instrument Parts, Gaskets & Tubing

Product type:

Medical Part

Description

Specification

item	Medical Silicone Rubber Products
Place of Origin	China
	Guangdong
Processing Service	Moulding Processing
Brand Name	HS
Model Number	MS-02
Material	Silicone
Product name	Medical Silicone
Color	Custom
Size	Customized Size
Application	Medical Consumable
Usage	Multi-function
Properties	Silicone Medical Tube
Certificate	ISO9001/IATF16949/CE/ RoHS
MOQ	500
OEM & ODM	Accptable

Based in Dongguan, Guangdong—China’s premier hub for medical-grade silicone manufacturing—HS specializes in FDA compliant custom silicone medical components, precision-engineered for medical devices, instrument parts, gaskets, and silicone medical tubing. Our MS-02 medical silicone rubber products are crafted via advanced moulding processing, certified to ISO9001/IATF16949/CE/RoHS standards, and offer full customization (size/color), a 500-piece MOQ, and OEM/ODM support to meet the rigorous demands of global medical device manufacturers. Whether you require precision gaskets for diagnostic instruments or biocompatible silicone tubing for fluid delivery systems, our components combine regulatory compliance, precision, and durability to elevate medical device performance and safety.

Core Features of Our Silicone Medical Components
Our silicone medical components stand out for their FDA compliance, precision engineering, and multi-functional medical-grade performance—key traits that make them ideal for medical devices, instrument parts, gaskets, and silicone medical tubing.First, regulatory compliance and biocompatibility define our silicone medical components: Premium medical-grade silicone is FDA-approved for human contact, hypoallergenic, and free of phthalates/BPA, ensuring safety for use in invasive and non-invasive medical devices. The material also exhibits exceptional chemical resistance to bodily fluids, medications, and sterilization agents (autoclaving, EO gas), maintaining integrity across repeated sterilization cycles critical for medical consumables.Second, precision engineering is central to our silicone medical components. Our moulding processing achieves a tolerance of ±0.02mm, enabling customized sizes and complex shapes for medical instrument parts, gaskets with tight sealing tolerances, and silicone medical tubing with uniform wall thickness (critical for consistent fluid flow). We offer custom colors (including transparent/opaque options) to align with device branding or functional visibility needs, without compromising biocompatibility.Third, durable multi-functional design is embedded in every silicone medical component. The robust silicone composition resists fatigue, compression set, and temperature fluctuations (-40°C to 230°C), ensuring long-term reliability in high-use medical devices—from diagnostic instrument gaskets to continuous-flow silicone medical tubing.

Competitive Advantages of Our Silicone Medical Components
Choosing our silicone medical components means partnering with a certified manufacturer with 20+ years of medical silicone expertise, prioritizing compliance, precision, and scalability for medical device clients.
Multi-Certification Compliance & Rigorous Quality Control
Our silicone medical components are fully certified to FDA, ISO9001/IATF16949/CE/RoHS standards, with every batch undergoing 100% quality inspection—including biocompatibility testing, dimensional precision checks, sterilization resistance validation, and chemical purity screening. This strict quality control ensures zero defects and adherence to global medical device regulatory requirements, reducing compliance risk for manufacturers.
Customization Flexibility & Scalable Production
We offer a 500-piece MOQ for silicone medical components, catering to small medical device startups and research labs, while our 10,000-square-meter production facility and automated moulding lines enable bulk orders for major medical OEMs. Full OEM/ODM support includes custom sizes, shapes, hardness levels, and finishes (e.g., smooth tubing for fluid delivery, textured gaskets for grip), with free design consultations to optimize component performance for specific medical applications.
Cost-Effective Factory-Direct Pricing
As a factory-direct manufacturer, we eliminate middlemen to offer competitive pricing on FDA-compliant silicone medical components without compromising precision or compliance. Our streamlined production process (from prototyping to mass production) reduces lead times by 20% compared to industry averages, ensuring on-time delivery for medical device production schedules.
Technical Expertise & Medical Industry Support
Our team of silicone engineering specialists with medical device experience provides 24/7 support—from material selection guidance (e.g., high-flex silicone for tubing, rigid silicone for instrument parts) to regulatory documentation assistance (certificate of compliance for FDA/CE submissions). We leverage deep knowledge of medical device design to solve complex sealing, fluid delivery, and biocompatibility challenges for our clients.

Applications of Our Silicone Medical Components
Our versatile silicone medical components serve critical roles across medical device categories, thanks to their FDA compliance and precision engineering:

Medical Diagnostic Instruments: Precision-molded silicone gaskets seal sensor ports and enclosures in blood analyzers, imaging equipment, and lab instruments—their tight tolerances prevent contamination, while chemical resistance withstands harsh lab reagents.
Fluid Delivery Systems: Custom-sized silicone medical tubing transports medications, saline, and bodily fluids in infusion pumps, catheters, and feeding systems—its biocompatible, kink-resistant design ensures consistent flow and patient safety.
Surgical Instrument Parts: Silicone components (gaskets, seals) for surgical tools and laparoscopic instruments—their sterilization resistance and durability withstand repeated autoclaving, reducing instrument replacement costs for hospitals.
Patient Monitoring Devices: Soft silicone gaskets and seals for pulse oximeters, ECG machines, and vital sign monitors—their hypoallergenic design prevents skin irritation during extended patient contact, enhancing comfort and compliance.
Home Medical Devices: Silicone medical tubing and gaskets for nebulizers, oxygen concentrators, and blood pressure monitors—their multi-functional design adapts to compact home device enclosures, while FDA compliance ensures consumer safety for at-home use.

At our Dongguan manufacturing facility, we adhere to ISO Class 8 cleanroom standards for silicone medical component production, minimizing particulate contamination and ensuring the highest level of purity for medical applications. We back all silicone medical components with a 3-year warranty against manufacturing defects, and offer lifetime technical support for all custom component designs. Whether you need precision gaskets for diagnostic instruments or FDA-compliant silicone tubing for infusion systems, we deliver silicone medical components that combine compliance, performance, and value—engineered for medicine, built to heal.

Product Description

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Company Profile

Founded in 2003, Dongguan Huangshi Rubber & Plastic Tech Co., Ltd. is one of the famous silicone and plastic products manufacturers. Our factory is located in Chang'an Town, Dongguan City, enjoying good location and convenient transportation access. Being specialized in silicon mold making,plastic mold making and silicon and plastic products manufacturing, we always try our best to provide you with best-quality products. With a workshop of 6,000 square meters and a serious QC department, we are professional in making all kinds of silicone and plastic cases for cells phones, MP3, MP4 and MP5 players, silicone keyboards, silicone series parts of electronic goods, silicone kitchen accessories and silicone toys. We are sure to make better quality and better price silicone rubber and plastic products for you. Our main foreign trade markets include Southeast Asia, Europe and America. We also provide ODM/OEM products for many national famous companies. In order to satisfy different requirements from our clients, we import raw materials and machines to make our goods reach the standards of RoHS, ISO, SGS and EN71. "Do a good job at first time; do a better job every time" is our tenet. Please don't hesitate to contact us if you have any problem. We must be the one which you can trust in. We look forward to your requirements. Choose us,and we can do better for you!

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FDA Compliant Custom Silicone Medical Components - Precision-Engineered for Medical Devices, Instrument Parts, Gaskets & Tubing

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