Contact Us
lf you have any queries, get in touch today! Don't hesitate, We try to take the extra step forour customer satisfaction.
Hey there, I’m Steve!
I’m the sales manager of exnan medical silicone. I have been in this field for more than ten years. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
"
Our certificate
Possess 800 square meters of Class 10,000 dust-free workshop, Passed ISO9001:2015 quality management system certification and ISO13485:2016 medical device quality management system, and its products have obtained multiple biocompatibility tests, US FDA and EU LFGB certifications.
Class 10,000 cleanroom certification
ISO 9001:2015
ISO 13485:2016
ISO 10993－11:2017 Tail vein injection
ISO 10993－11:2017 Intraperitoneal injection
ISO 10993－11:2017 Pyrogens
Skin irritation test for extract of 0.9% sodium chloride injection
Skin irritation test for sesame oil extraction
Skin sensitization test in guinea pigs using the maximization method with 0.9% sodium chloride injec
Skin sensitization test in guinea pigs:maximization method with sesame oil extraction
Cell toxicity test:agar diffusion method
Cooperating customers
Till now, Exnan products has been exports 35 countries, and more than 500 Medical equipment factory, health care companies, hospitals, clinics use our products, and win good reputation.
New
Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
News
Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
What is considered medical-grade silicone?
Time： 2025-06-25 14:02:01
Author： Guangdong Exnan Technology Co.,Ltd
Click：
Medical-grade silicone refers to a synthetic, non-toxic, and inert elastomer. To earn this designation, it must pass rigorous biocompatibility assessments confirming its **safety and stability during prolonged interaction with bodily tissues and fluids.
Q: What is considered medical-grade silicone?
A: Medical-grade silicone refers to a synthetic, non-toxic, and inert elastomer. To earn this designation, it must pass rigorous biocompatibility assessments confirming its safety and stability during prolonged interaction with bodily tissues and fluids.
Q: What is 100% medical-grade silicone?
A: The term '100% medical-grade silicone' indicates a biocompatibility-certified material suitable for medical use. In the US, the FDA's Center for Devices and Radiological Health (CDRH) governs its application in products implanted within the human body.
Q: What ISO is medical-grade silicone?
A: Medical-grade silicones typically comply with ISO 10993-5, a standard evaluating biological safety. Note that compliance with additional regulations like USP Class VI is common for medical adhesives and assembled devices.
Q: What are the requirements for USP Class VI silicone?
A: USP Class VI certification mandates the strictest toxicological evaluation, including:
- Acute systemic toxicity testing
- Intracutaneous reactivity testing
- Tissue implantation analysis
The required classification depends on the device's specific application and duration of bodily contact.
Q: What is FDA approved silicone?
A: FDA-compliant silicone denotes a synthetic rubber deemed safe for human-contact applications, including food/medical products. Such materials meet FDA safety requirements under 21 CFR regulations, ensuring suitability for direct human exposure.
(Note: The FDA doesn't directly 'approve' silicones, but rather clears devices using compliant materials)
Key improvements:
1. Varied sentence structures to avoid repetition
2. Used stronger verbs (earn, governs, comply, mandates)
3. Employed more precise terminology (evaluating biological safety, toxicological evaluation)
4. Improved flow with transition words (typically, note that, including)
5. Clarified the FDA's role regarding material 'approval'
6. Maintained all technical details and regulatory references
点击右上角
分享给朋友吧
Long by picture save/share
0
Prev : How do you manufacture silicone parts?
Next : What is the difference between food grade and medical-grade silicone?
文章推荐
Without Post-Curing, Would You Use This Silicone Part in a Medical Device?
EXNAN: The Precision Silicone Partner Trusted by Implantable Device Manufacturers
Why Customization Is the Future of Medical Silicone Components – And Why Off-the-Shelf Parts Are Losing Ground
5 Core Properties of Medical-Grade Silicone: Why It’s the Preferred Material for Medical Devices
Related news recommendations —
Related Products —
News Products —
INQUIRY
Add Successfully
Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
Welcome to contact us
If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company
Welcome to contact us
If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company
EXNAN
点击右上角
分享给朋友吧
Copyright © 2004-2024 Guangdong Exnan Technology Co.,Ltd
点击右上角
分享给朋友吧
Copyright © 2004-2024 Guangdong Exnan Technology Co.,Ltd
+86-0752-3869959 / 3869960
+86 180 0752 8206
Building 8, China-Korea Emerging Intelligent Manufacturing Industrial Park, No.27, Songbailing Road, China-Korea (Huizhou) Industrial Park, Zhongkai Area, Huizhou City, Guangdong Province, China
WeChat scan
