FDA Approved Custom Silicone Medical High-Precision Manufacturing Full OEM/ODM Support Custom Sizes Shapes Specifications Rubber

FDA Approved Custom Silicone Medical High-Precision Manufacturing Full OEM/ODM Support Custom Sizes Shapes Specifications Rubber

Product type:

Medical Part

Description

Specification

item	Silicone Medical Accessories
Place of Origin	China
	Guangdong
Processing Service	Moulding Processing
Brand Name	HS
Model Number	MS-05
Material	Silicone
Product name	Silicone Medical Parts
Application	Mechanical Equipment
Color	Customer's Request
Size	Customized Accepted
Feature	Eco-friendly
Usage	Medical Accessories
MOQ	500pcs
OEM/ODM	Aavailable
Sample	Availabe

Based in Dongguan, Guangdong—China’s premier hub for medical-grade silicone manufacturing—HS specializes in FDA approved custom silicone medical parts, delivering high-precision moulded solutions with full OEM/ODM support for custom sizes, shapes, and specifications across medical accessories and mechanical equipment applications. Our MS-05 silicone medical accessories are crafted from eco-friendly medical-grade silicone, with a 500-piece MOQ, free samples available, and customizable colors to meet the stringent safety and performance demands of global medical device manufacturers. Whether you require precision-molded silicone gaskets for diagnostic equipment or custom-shaped seals for medical machinery, our FDA-compliant silicone medical parts combine biocompatibility, high-precision engineering, and design flexibility to elevate medical device reliability and safety.

Core Features of Our Silicone Medical Parts
Our silicone medical parts stand out for their FDA approval, high-precision manufacturing, and eco-friendly medical-grade performance—key traits that make them ideal for medical accessories and medical-focused mechanical equipment applications.First, regulatory compliance and biocompatibility define our silicone medical parts: Premium eco-friendly silicone is fully FDA-approved for human contact, hypoallergenic, and free of harmful additives (phthalates, BPA), ensuring safety for use in invasive and non-invasive medical devices. The material also resists sterilization processes (autoclaving, EO gas, gamma radiation) without degradation, maintaining structural integrity across repeated sterilization cycles critical for reusable medical accessories.Second, high-precision moulding is central to our silicone medical parts. Our moulding processing achieves a tolerance of ±0.02mm, enabling customized sizes, complex shapes, and tight-specification designs to fit intricate medical machinery components—from micro-sized seals for infusion pumps to large gaskets for diagnostic equipment enclosures. We offer customer-requested colors (transparent, opaque, or tinted shades) to align with device branding or functional visibility needs, without compromising biocompatibility or precision.Third, durable eco-friendly design is embedded in every silicone medical part. The robust silicone composition resists chemical exposure to bodily fluids, medications, and cleaning agents, while its eco-friendly formulation aligns with global sustainability standards for medical device manufacturing. The parts maintain flexibility and structural stability across extreme temperatures (-40°C to 230°C), ensuring long-term reliability in high-use medical environments.

Competitive Advantages of Our Silicone Medical Parts & OEM/ODM Services
Choosing our silicone medical parts means partnering with a high-precision manufacturer with 20+ years of medical silicone expertise, prioritizing compliance, customization, and scalability for medical device clients.
FDA Compliance & Rigorous Quality Control
Our silicone medical parts are fully validated to FDA standards, with every batch undergoing 100% quality inspection—including biocompatibility testing, dimensional precision checks, sterilization resistance validation, and eco-friendly material screening. This strict quality control ensures zero defects and adherence to global medical device regulatory requirements, reducing compliance risk for manufacturers and enhancing patient safety.
Full OEM/ODM Customization & Scalable Production
We offer end-to-end OEM/ODM support for silicone medical parts: custom sizes, shapes, and specifications per client drawings (CAD/STEP formats), color customization, and even functional texture optimization (e.g., anti-slip surfaces for medical tool grips). With a 500-piece MOQ, we cater 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—ensuring on-time delivery for production schedules.
Cost-Effective Factory-Direct Pricing
As a factory-direct manufacturer, we eliminate middlemen to offer competitive pricing on FDA-approved silicone medical parts without compromising high-precision or eco-friendly quality. Our streamlined production process (from prototyping with free samples to mass production) reduces lead times by 25% compared to industry averages, optimizing supply chain efficiency for medical device clients.
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 catheter accessories, rigid silicone for diagnostic equipment parts) to regulatory documentation assistance (FDA compliance certificates). We leverage deep knowledge of medical device design to solve complex precision and biocompatibility challenges for our clients.

Applications of Our Silicone Medical Parts
Our versatile silicone medical parts serve critical roles across medical accessories and medical mechanical equipment, thanks to their FDA approval and high-precision design:

Diagnostic Equipment Components: High-precision silicone medical parts act as gaskets and seals for blood analyzers, imaging machines, and lab testing equipment—their tight tolerances prevent fluid leaks and contamination, while sterilization resistance ensures reliable performance in clinical settings.
Infusion & Delivery Systems: Custom-sized silicone medical parts fit infusion pumps, medication delivery tubes, and syringe components—biocompatibility ensures patient safety, and eco-friendly material aligns with sustainable healthcare initiatives.
Surgical Tool Accessories: Silicone medical parts (grips, seals) for laparoscopic instruments and surgical hand tools—anti-slip texture enhances surgeon grip, and FDA compliance ensures safety for intraoperative use.
Home Medical Devices: Custom-shaped silicone medical parts for nebulizers, oxygen concentrators, and blood pressure monitors—durability withstands daily home use, and customizable sizes fit compact home medical equipment enclosures.
Reusable Medical Accessories: Eco-friendly silicone medical parts for reusable face masks, wound care dressings, and patient positioning aids—hypoallergenic design prevents skin irritation, and sterilization resistance extends product lifespan.

At our Dongguan manufacturing facility, we adhere to ISO Class 8 cleanroom standards for silicone medical part production, minimizing particulate contamination and ensuring the highest level of purity for medical applications. We back all silicone medical parts with a 3-year warranty against manufacturing defects, and offer lifetime technical support for all custom OEM/ODM designs. Whether you need high-precision seals for diagnostic equipment or custom-shaped accessories for home medical devices, we deliver silicone medical parts that combine compliance, precision, and sustainability—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 Approved Custom Silicone Medical High-Precision Manufacturing Full OEM/ODM Support Custom Sizes Shapes Specifications Rubber

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