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A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potentially infectious and other contaminants.

A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material.

The provided document is a 510(k) premarket notification letter from the FDA for medical examination gloves. It is not a study report for an AI/ML device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to the content of this document.

The document states:

• Device Name: Emerald Medical, Inc. Syntheticare Powder-Free Vinyl Patient Examination Gloves
• Regulation Name: Patient Examination Gloves
• Regulatory Class: I
• Product Code: LYZ

This type of device (patient examination gloves) is a physical medical product, not a software or AI-driven diagnostic device. The FDA's decision is based on substantial equivalence to a legally marketed predicate device, rather than a clinical study demonstrating performance against specific acceptance criteria for an AI algorithm.

To answer your questions, I would need a different type of document, specifically a study report or clinical validation report for an AI/ML medical device.

Ask a specific question about this device