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A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.

Powdered Patient Nitrile Examination Gloves (White / Blue color)

The provided document is an FDA 510(k) clearance letter for "Powdered Patient Nitrile Examination Gloves (White/Blue Color)." This document does not contain information about acceptance criteria or a study proving that a device (in the sense of a software algorithm or diagnostic tool) meets acceptance criteria.

The letter pertains to the substantial equivalence of a physical medical device (gloves), and therefore the questions about algorithm performance, ground truth, expert review, sample sizes for training/test sets, and MRMC studies are not applicable.

The document states:

• Device Name: Powdered Patient Nitrile Examination Gloves (White/Blue Color)
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Product Code: LZA
• Indications for Use: A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.

This is a regulatory clearance for a physical product, not a software or AI-driven diagnostic device. Therefore, the requested information (table of performance, sample sizes for test/training, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, etc.) is not present in this type of document.

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