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

Powder-free Nitrile Patient Examination Glove BLUE AND WHITE

This document is a 510(k) clearance letter from the FDA for a Powder-Free Nitrile Examination Glove. It is not a study or a technical report that would contain the detailed information requested about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested information from the provided text. The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail the specific performance studies, acceptance criteria, or ground truth establishment that would be part of such a submission.

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As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Powder-Free Nitrile Examination Glove, Blue or White (non-colored)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Powder-Free Nitrile Examination Glove). This document explicitly states that the device is "substantially equivalent" to previously marketed devices and permits the device to proceed to the market.

However, the letter does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used, or details about a training set.

The FDA 510(k) clearance process for devices like examination gloves primarily focuses on demonstrating substantial equivalence to a predicate device, often through a comparison of physical and chemical properties and performance standards (e.g., ASTM standards for barrier integrity). While performance data is submitted as part of the 510(k), this specific letter does not elaborate on these study details.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device