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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Powder Free Vinyl Examination Gloves

This document is a 510(k) clearance letter from the FDA for Powder Free Vinyl Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or performance evaluation section.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory compliance rather than detailed technical or clinical performance data.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves

The provided documents are FDA correspondence regarding a 510(k) premarket notification for "Disposable Powdered Vinyl Patient Examination Gloves." This type of document is a regulatory approval and does not contain the detailed performance study information requested about acceptance criteria, sample sizes, ground truth establishment, or AI-related metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device based on general safety and effectiveness.

Therefore, I cannot extract the requested information from the provided text. The document states that the device is "substantially equivalent ... to legally marketed predicate devices," implying that its performance is considered acceptable by meeting the standards established for those predicate devices. However, the specific study details are not present.

Ask a specific question about this device