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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or lingers to prevent contamination between patient and examiner.

White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.

The provided document is a 510(k) summary for the "White Vinyl Exam Gloves Powder Free." This is a medical device application for approval based on substantial equivalence to an already marketed predicate device, not a clinical study report for an artificial intelligence or diagnostic device. Therefore, many of the requested elements are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data as presented for the non-clinical tests conducted to demonstrate substantial equivalence of the proposed device to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (medical gloves), the "acceptance criteria" are typically defined by recognized standards (like ASTM D5250-06) and the performance of the predicate device. The "device performance" refers to the results obtained from testing the proposed device against these standards and in comparison to the predicate.

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