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A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Colored Powder Free And Polymer Coated Nitrile Examination Glove (White, Blue and Black)

This document is a 510(k) summary for a Nitrile Examination Glove. It is a regulatory clearance letter from the FDA, and as such, it does not contain the kind of detailed study information you are asking for (acceptance criteria for algorithmic performance, sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).

The purpose of a 510(k) submission for this type of Class I medical device (patient examination glove) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance metrics through detailed studies. The acceptance criteria for such a device would typically relate to physical properties (e.g., tensile strength, elongation, barrier integrity like pinhole rate) and biocompatibility, as well as labeling requirements. These are usually established through recognized consensus standards rather than clinical performance studies of an algorithm.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory classification and clearance.

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