Durable Customized Medical Silicone Components with Medical Grade Silicone Rubber Product

Product Description

Product Description

Customized Medical Silicone Components

We are a specialized manufacturer of precision Medical Silicone Rubber Products and Custom Medical Silicone Components, utilizing advanced Liquid Silicone Rubber (LSR) manufacturing processes under a strict ISO 13485 certified quality management system. Our expertise lies in producing high-purity, biocompatible, and reliable liquid silicone products for critical healthcare applications, including respiratory masks, seals, catheter components, and fluid transfer tubing. We offer comprehensive OEM/ODM services, partnering with medical device brands from concept and material validation through to full-scale production, ensuring each custom silicone product meets the most demanding performance and regulatory standards. As a trusted silicone products manufacturer, we are committed to delivering exceptional quality, consistency, and safety for all your medical silicone components needs.

Our Advantages

1. Precision Mold-Making Technology. 

2. Competitive Price: original manufacturer.

3. Proffessional Support: offer technology/production/design/artwork support etc.

4. Strictly Quality management: ISO 9001 and ISO 13485 (for medical devices).

5. High-Volume Precision Production: Advanced manufacturing facilities capable of delivering consistent, high-quality parts at scale.

Parameter Category	Specification / Property	Standard / Value	Remarks / Application
Material & Certification	Material Grade	Medical Grade LSR (Platinum-Cured)	USP Class VI, ISO 10993, FDA 21 CFR 177.2600 compliant
	Quality Management System	ISO 13485:2016 Certified	Full traceability for medical device manufacturing
Physical Properties	Hardness (Shore A)	10 A to 80 A	Customizable based on component function (e.g., soft seals, rigid housings)
	Tensile Strength	≥ 8 MPa	Ensures durability and tear resistance in dynamic applications
	Elongation at Break	≥ 400%	Provides excellent flexibility and elongation for safety
	Tear Strength	≥ 25 kN/m	Resists nicking and propagation of tears
Performance Properties	Temperature Resistance	-50°C to +200°C	Suitable for autoclaving (steam sterilization) and cryogenic conditions
	Biocompatibility	Certified	Non-toxic, non-allergenic, supports long-term skin/fluid contact
	Transparency	Optically Clear to Opaque	Available in full range; clarity ideal for fluid monitoring components
	Compression Set (22 hrs @ 175°C)	≤ 20%	Maintains seal integrity after repeated sterilization cycles
Surface & Processing	Surface Finish	Medical Smooth, Textured, or Custom	Minimizes bacterial adhesion; customizable for grip or aesthetics
	Color	Natural, Standard Pantone, or Custom	Non-migrating, pigment masterbatches compliant with medical standards
	Secondary Operations	Bonding, Printing, Assembly	Can be securely bonded to plastics, metals, or other substrates
Customization & Service	Manufacturing Process	Liquid Silicone Injection Molding (LSR/LIM)	Precision molding for complex, flash-free, high-volume parts
	Tolerances	Tight, ISO 20457 (DIN 7715)	Meets medical component dimensional requirements
	Services Offered	Full OEM & ODM	From design & prototyping to validation, packaging, and logistics
	Lead Time for Prototypes	2-4 weeks	Subject to project complexity

Main Products

Company Profile

Kingod Silicone Products Co., Ltd. was established in 2007. we are a high-tech company focused on custom processing services for silicone products. Our company was located in ShenZhen Guangdong province and with a modern factory buildings of more than 3000 square meters.
 
Our company is a professional custom manufacturer of LSR silicone products, covering a wide range of applications including baby products, medical products, kitchenware, household, and industrial parts. Our factory utilizes advanced production technologies, including LSR injection molding and HTV molding. We have unique advantages in the one-piece molding technology of silicone and other materials, such as metal with silicone overmolding manufacturing, plastic with Silicone Overmolding Manufacturing, and Glass With Silicone Overmolding Manufacturing ect.

So whether you need food-grade baby products, medical-grade silicone products, Industrial Silicone Products, or custom silicone solutions, we have the expertise, experience, and silicone molding techniques to deliver top-quality products. We aim to be your silicone manufacturer of choice, committed to meeting the high standards of the industry.

We are committed to provide high-quality products and guarantee strict confidentiality of your proprietary manufacturing information, we are always place client interests first, and strive for excellence in every service we provide.

Production Process

Certifications

Packaging & Shipping

FAQ

1. Question: You are the production plant or a trading company? 
Answer: We are professional manufacturer of liquid and solid silicone products, silicone kitchen silicone medical supplies and life of parts manufacturers. 

2. Question: You are currently several machine, how much per month to achieve? 
Answer: We now have 7 sets of liquid silicone injection molding machine, solid molding curing machine 15, two-roll open mixing machine 2, the 15-meter line baking pull, efficient ovens, silk printing machine 10, red beer 20 silicone products such as high efficiency equipment. The current monthly production of 50 tons. 

3. Question: What are your main products, some in the industry What are the advantages? 
Answer: Our main products are silicone liquid silicone nipple and baby products categories, liquid silicone utensils, liquid silicone medical accessories, daily necessities of solid silicone and solid silicone gifts and other series. Technical staff in this industry for over 20 years of length of service, we continue to progress and R & D, to capture a lot of technical difficulties, such as yellow question silica, silica gel and plastic and metal bonding problems, and so silicone and nylon. 

4. Question: how about your production? 
Answer: We are now liquid silicone plant, pacifiers month's production capacity is now 2,000,000, about 50 tons per month of solid silicone! 

5. Question: How many you have ready-made mold you, need to charge for proofing? 
Answer: We have 8 sets of liquid silicone nipples wide. Standard port die, solid silicone involving 100 sets of cutlery and other household items around the mold, solid silicone more color, and number of other comprehensive accounting of costs, proof fee will be refunded after the order. Liquid silicone is true, the current sample do not charge a fee .

6. Question: What is your product test reports? 
Answer: We are SGS, FDA, LFGB, HORS, CE Environmental test report. 

7. Question: How long is the leadtime? 
Answer: depends on the different products, different number, in general, is 7 days. 

8. Question: how do you control the production quality? 
Answer: We have professional QC team will start from raw material QC, production of 4 to testing procedures, to ensure the quality of your product.