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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim ( 50ug or less )

The provided text is a 510(k) premarket notification decision letter from the FDA to OmniGrace (Thailand) Ltd. for their Latex Examination Glove, Powder-Free, Polymer Coated, with Protein Content Labeling Claim (50 Micrograms or Less). This document states the FDA's determination of substantial equivalence to a legally marketed predicate device, thereby allowing the device to be marketed.

Crucially, the provided text does NOT contain information about acceptance criteria, device performance, test set sample size, ground truth establishment, or any details about a study conducted to prove the device meets acceptance criteria.

The letter is an administrative document, confirming regulatory clearance based on substantial equivalence to an existing device, rather than a report detailing a new study or performance evaluation with specific acceptance criteria as you've requested.

Therefore, I cannot extract the information you've requested from the provided text.

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