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Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.

Gowns are provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.

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The provided document is a 510(k) premarket notification letter for a medical device (Jiehong Medical Surgical Gown). This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document primarily focuses on:

• Substantial equivalence determination for a physical product (surgical gown).
• Regulatory classifications and requirements.
• Indications for Use for the surgical gown.
• Material, gown style, sterility, sizes, and model numbers of the surgical gowns.

In summary, this document cannot be used to answer the questions you've posed about acceptance criteria and device performance studies related to AI/ML devices.

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