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A patient 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.

POWDER FREE LATEX EXMAINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 µg/dm² OR LESS

This document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Latex Examination Gloves with Protein Content Labeling Claim of 50 ug/dm2 or Less." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on confirming the substantial equivalence of the device to legally marketed predicate devices and outlines the regulatory obligations of the manufacturer. There is no performance data, study design, or expert review mentioned within this text.

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Natural Rubber Late: a non-colored, single use amination ce inte on the hand of med nded to If to prevent contamination between the patie neand examine

POWDERED LATEX EXAMINATION GLOVES (NON-COLORED)

The provided text is an FDA 510(k) clearance letter for Powdered Latex Examination Gloves (Non-Colored). It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The document is a regulatory communication confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines general controls, manufacturing practices, and reporting requirements for the device.

Therefore, I cannot provide the requested information based on the given input text.

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