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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, Poly-Coated Nitrile Examination Glove, Purple or White (noncolored)

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder-Free Nitrile, Poly-Coated Examination Glove, Purple or White (Non-colored)".

The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document.

This letter is a regulatory approval notice, indicating that the device has been found substantially equivalent to a pre-existing legally marketed device. It does not contain the detailed technical performance study results, acceptance criteria, or specific ground truth methodologies that would typically be found in a 510(k) submission's performance data section.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.

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

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

I am sorry, but the provided text from the FDA 510(k) letter does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter is a notification of substantial equivalence for a Powdered Nitrile Examination Glove. It discusses the regulatory classification, general controls, and compliance with manufacturing practices, but it does not detail specific performance studies or acceptance criteria for the glove's functionality beyond its general indication for use as a medical glove. Therefore, I cannot generate the requested information based on this input.

Ask a specific question about this device

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.

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