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A blue powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.

Blue Powder-Free Nitrile Examination Gloves

The provided document is a 510(k) premarket notification letter from the FDA for "Blue Powder-Free Nitrile Examination Gloves." This document does not contain information about a study proving the device meets specific acceptance criteria in the manner described by your request (e.g., performance metrics like sensitivity, specificity, or AUC, sample sizes for test/training sets, expert qualifications, or adjudication methods).

The letter indicates that the device has been determined to be "substantially equivalent" to legally marketed predicate devices already on the market prior to May 28, 1976. This is a regulatory pathway for medical devices where the manufacturer demonstrates that their new device is as safe and effective as an already legally marketed device, often through comparison of technological characteristics and performance data to established standards or predicate device specifications, rather than through a novel clinical study with explicit acceptance criteria for diagnostic performance metrics.

Therefore, I cannot fulfill your request for the specific study details you've asked for based on the provided text. The FDA's 510(k) clearance process for this type of device (nitrile examination gloves) typically focuses on material safety, barrier integrity, and physical properties (like tensile strength and elongation) rather than diagnostic accuracy or clinical efficacy studies with ground truth establishment as would be common for AI/diagnostic software.

If you have a document describing a performance study for a different type of device (e.g., AI-powered diagnostic software), please provide that document, and I would be happy to analyze it according to your requested criteria.

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A powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.

POWDER-FREE NITRILE EXAMINATION GLOVES

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) clearance letter from the FDA for "Powder-Free Nitrile Examination Gloves."

This letter indicates that the device is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. However, it does not detail specific performance metrics, acceptance criteria, or a study that directly demonstrates the device meets such criteria. Instead, it mentions general controls provisions and compliance with Good Manufacturing Practice (GMP) requirements.

Therefore, I cannot extract the information required to populate the table and answer your questions regarding acceptance criteria and study details.

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A medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.

Powdered Nitrile Examination Gloves

This document is a 510(k) premarket notification from the FDA for Powdered Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving device performance as it is a regulatory clearance document rather than a performance study report.

Therefore, I cannot provide the requested information.

Ask a specific question about this device