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A patient examination glove 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.

Vinyl Examination Gloves, Powder Free, Pink Color

This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves, Powder Free, Pink Color." It states that the device is substantially equivalent to legally marketed predicate devices.

The information provided in the document does not contain details about acceptance criteria, device performance, study types, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device in a clinical or diagnostic context.

Instead, the document primarily focuses on the regulatory approval process for a patient examination glove, confirming its substantial equivalence to predicate devices for its intended use (preventing contamination between patient and examiner). The "Indicators For Use" section defines the product, but does not specify performance metrics.

Therefore, I cannot provide the requested information based on the input text. The text is a regulatory approval letter, not a performance study report.

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