(204 days)
The Gammex(R) Cut Resistant Glove Liner is a single use glove liner intended to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.
Cut resistant under glove liner is a white color liner knitted from an ultrahigh molecular weight polyethylene fiber (UHMWPE) that offers ANSI/ISEA 105 Cut Level Protection against cuts. The liner is knitted using the UHMWPE as the main strengthening component along with nylon and spandex for comfort. The device is a single use device.
The provided text does not describe an AI/ML powered medical device. Instead, it is an FDA 510(k) premarket notification for a medical device called "Gammex® Cut Resistant Glove Liner."
Therefore, it is not possible to answer the request based on the provided document as the questions are specific to the acceptance criteria and study design for an AI/ML powered device.
The document focuses on demonstrating that a cut-resistant glove liner is "substantially equivalent" to a legally marketed predicate device, primarily through performance data against standards (e.g., ANSI/ISEA 105 for cut level, ISO 10993 for biocompatibility) rather than clinical studies or AI model performance.
§ 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).