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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.
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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.
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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!
Is medical grade silicone FDA approved?
Time： 2025-02-22 00:00:00
Author： Guangdong Exnan Technology Co.,Ltd
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Medical grade silicone rubber is a specialized form of silicone that adheres to the biocompatibility and safety criteria established by regulatory authorities such as the FDA and ISO. It is specifically designed for medical applications involving potential contact with human tissue, blood, and other bodily fluids.
Q: Is medical grade silicone FDA approved?
A: Medical grade silicone rubber is a specialized form of silicone that adheres to the biocompatibility and safety criteria established by regulatory authorities such as the FDA and ISO. It is specifically designed for medical applications involving potential contact with human tissue, blood, and other bodily fluids.
Q: What distinguishes ISO from FDA?
A: In general, ISO tends to have a broader focus on various types of feedback, while the FDA is more narrowly concentrated on establishing processes for handling complaints. ISO encourages the solicitation of both positive and negative feedback, whereas the FDA adopts a more reactive stance, emphasizing the specifics of your complaints handling process.
Q: Why is ISO 13485 certification significant?
A: Attaining ISO 13485 accreditation offers several key advantages. It assures organizations worldwide of the quality of your practices and, consequently, the medical devices you handle. Additionally, global recognition facilitates easier entry into international markets.
Q: What does ISO stand for in the context of medical products?
A: Who is ISO 13485 intended for? ISO 13485 is tailored for organizations engaged in the design, production, installation, and servicing of medical devices and related services. It is also applicable for internal and external parties, such as certification bodies, to assist in their auditing processes.
Q: How does silicone differ from medical silicone?
A: UNDERSTANDING MEDICAL GRADE SILICONE
The primary distinction between conventional silicone and medical grade silicone lies in the curing system employed. Conventional silicone utilizes the peroxide cure system, also known as a free radical cure system or a high temperature vulcanizing (HTV) system.
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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
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