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The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves ( with Protein Content Labeling Claim ) - GREEN 50 MICROGRAMS, OR LESS

The provided text is related to a 510(k) clearance letter for "Powder Free Latex Examination Gloves (with Protein Content Labeling Claim) - GREEN 50 MICROGRAMS, OR LESS". This document itself does not contain the acceptance criteria or a study proving the device meets those criteria, as typically found in a scientific or clinical study report.

Instead, this is a regulatory letter confirming that the device is "substantially equivalent" to predicate devices already on the market. This substantial equivalence determination is based on the information submitted by the manufacturer in their 510(k) notification.

Therefore, I cannot extract the requested information as it is not present in the provided document. The questions you asked are generally applicable to the evaluation of a new medical device through clinical trials or performance studies, which are typically summarized in a different kind of document than a 510(k) clearance letter.

To answer your request based on the provided text, I can only state that this document does not contain the information required to construct the table or answer the specific questions about acceptance criteria and study details.

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