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Feb 15, 2025

Is Surgical Gown A Medical Device?

Surgical gowns are medical devices. According to the relevant provisions of the "Medical Device Classification Catalog", surgical gowns are classified as medical devices, and specifically belong to Class II medical devices. This means that the production, sales and use of surgical gowns need to comply with relevant medical device regulations and management requirements.

As a medical device, the main function of surgical gowns is to protect medical staff from contamination by blood, body fluids and other potential contaminants during surgery, and also to reduce the microbial contamination of the surgical site by medical staff, thereby reducing the risk of surgical site infection. Therefore, surgical gowns need to meet certain standards and requirements during the design and manufacturing process to ensure their safety and effectiveness.

In addition, surgical gowns usually need to be cleaned and disinfected before use to ensure their sterility. At the same time, during the operation, medical staff also need to strictly abide by the principles of aseptic operation to avoid contamination of surgical gowns.

As a medical device, surgical gowns play an important role in the medical field, and their quality and safety are essential to ensure the success of the operation and the health of the patient.

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