(79 days)
The Ya Mei First Aid Kit is intended to provide basic first aid treatment for various emergency situations, while seeking further professional medical assistance, when necessary.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Ya Mei First Aid Kit." This document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory requirements the manufacturer must comply with.
- Stating the intended use of the device: "The Ya Mei First Aid Kit is intended to provide basic first aid treatment for various emergency situations, while seeking further professional medical assistance, when necessary."
Therefore, I cannot provide the requested table and study details based on the given information. The prompt asks for information that is simply not present in the provided FDA letter.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).