Congratulations to Tenkebaodi's reusable surgical drapes for obtaining the second-class device certificate, and the soft device products have been fully equipped!


On April 28, 2019, our new product "reusable surgical drapes" was registered by the Food and Drug Administration of Guangxi Zhuang Autonomous Region and approved for domestic marketing. It is the first and only reusable surgical drapes in China. Device registration certificate!

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Features

Tenkebaodi's reusable surgical drapes include three products: surgical drapes, surgical drapes, and instrument drapes. They are woven from medical long-fiber polyester fiber functional materials and carbon fiber conductive yarns, and have obtained a number of independent intellectual property rights and patents. It meets the performance requirements of my country's YY/T 0506.2-2016 surgical gown. Compared with cotton surgical drapes, it has the following functions:

1. It has the "self-cleaning" characteristics of anti-splash, oil-proof and anti-fouling;

2. It has a two-way barrier function of anti-penetration and anti-bacteria, preventing the migration of microorganisms and reducing the risk of surgical site infection in patients;

3. Permanent anti-static effect, which can effectively avoid the adsorption of tiny dust particles and reduce the interference to precision electronic equipment;

4. No flocculation, reduce surgical site infection (SSI) caused by insoluble fiber particles, and reduce cotton dust pollution in clean ventilation ducts;

5. Reusable up to 105 times, cost-effective, economical and environmentally friendly;

6. The heat preservation effect is better, reducing the incidence of hypothermia in patients;

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Product drawings are for reference only, the actual product shall prevail

What are soft instruments?

The new version of the "Medical Device Classification Catalog" implemented on August 1, 2018 has included reusable surgical gowns and surgical drapes into the management of Class II medical devices, followed by the official release of the "Basic Standards and Management Regulations for Medical Disinfection Supply Centers (Trial)" , put forward the concept of "soft instrument" for the first time:
Water-blocking, bacteria-blocking, breathable surgical gowns, surgical covers, etc., wearable, foldable infection control devices with two-way protection functions that meet the category of surgical devices.
Therefore, the surgical gowns and surgical drapes made of textile materials without medical device registration certificates used by domestic medical institutions will face the risk of investigation and punishment by the regulatory authorities for using medical device products without registration certificates.

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Tengkebaodi's "soft equipment" products have been fully equipped

On January 25, 2018, our company obtained the second-class medical device registration certificate for reusable surgical gowns, and on April 28, 2019, we obtained the second-class medical device registration certificate for reusable surgical drapes. So far, our company is the only medical device manufacturer in China with a complete range of soft device products, and will provide legal, compliant and high-quality products and services to more medical institutions, device management companies, and third-party decontamination centers!

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