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A patient examination glove is a disposable intended for medical purposes A patient examiner's hand or finger to prevent contamination between patient and examiner

Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)

Here's an analysis of the provided 510(k) summary, breaking down acceptance criteria and the study information as requested.

The provided document describes Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less). It is a submission for a 510(k) premarket notification, which is a process to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data and does not typically involve extensive human clinical trials or AI performance evaluations as described for complex AI/ML-based medical devices.

Therefore, many of the requested points related to AI/ML studies (test sets, ground truth establishment, MRMC studies, standalone performance, training sets) are not applicable to this type of device and submission.

1. Table of Acceptance Criteria and Reported Device Performance

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