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

Patient Vinyl Examination Gloves, PowderFree, Non-Sterile

This document is an FDA 510(k) clearance letter for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It explicitly states that the device is substantially equivalent to legally marketed predicate devices and does not require approval of a Premarket Approval Application (PMA).

However, the provided text does not contain any information about acceptance criteria, a study, or performance data for the device. The letter is an administrative notification of clearance based on equivalence, not a detailed report of a device's performance against specific criteria.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set.
• Data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

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