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The Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

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This document is a 510(k) clearance letter from the FDA for Powder Free Polyurethane Examination Gloves. It is not a document describing an AI/ML-driven medical device or software. Therefore, the information requested in your prompt (acceptance criteria, study details for AI/ML performance, ground truth establishment, etc.) cannot be extracted from this letter.

This letter confirms that the gloves are "substantially equivalent" to legally marketed predicate devices, meaning they meet the safety and effectiveness standards for their intended use as barrier protection. The "study" here refers to the documentation and evidence the manufacturer provided to demonstrate this substantial equivalence based on established performance characteristics for medical gloves (e.g., barrier integrity, tensile strength, biocompatibility), not an AI/ML efficacy study.

To answer your prompt, I would need a document related to the clearance of an AI/ML medical device, which typically includes detailed performance studies and acceptance criteria related to its algorithmic accuracy and clinical utility.

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