Search Results

The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.

The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.

The provided text is an FDA 510(k) clearance letter for a medical device: "Powder Free Vinyl Patient Examination Glove." This document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria for a diagnostic algorithm or AI-powered medical device.

The letter explicitly states:

• Device Name: Powder Free Vinyl Patient Examination Glove
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: Class I, reserved
• Product Code: LYZ

This is a physical, disposable medical glove, not a diagnostic algorithm or an AI system. The 510(k) clearance for such a device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, typically through performance standards for physical properties, biocompatibility, and manufacturing processes, rather than the type of clinical study outlined in your request (e.g., MRMC, standalone algorithm performance, ground truth establishment for AI/diagnostic devices).

Therefore, I cannot fulfill your request using the provided text because it describes a completely different type of medical device and does not include the information you've asked for regarding acceptance criteria and performance studies for an AI or diagnostic algorithm.

Ask a specific question about this device

A Powder Free Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Vinyl Examination Gloves

I regret that I cannot fulfill your request to describe the acceptance criteria and study for a medical device based on the provided text. The document you've shared is an FDA 510(k) clearance letter for "Powder Free Vinyl Examination Glove" (K122377).

This type of document primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device. It does not typically contain the detailed information about acceptance criteria, the specific studies performed to prove the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment that you've requested.

The FDA 510(k) clearance process for Class I devices like examination gloves often relies on demonstrating equivalence to existing devices rather than requiring extensive de novo clinical trials with detailed performance metrics and statistical analyses as might be seen for higher-risk devices or novel technologies.

Therefore, the information necessary to answer your specific questions (e.g., a table of acceptance criteria and performance, sample sizes for test/training sets, details on expert ground truth, MRMC studies, standalone performance) is not available within these pages.

Ask a specific question about this device

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Powder Free Vinyl Examination Gloves

I'm sorry, but without further context, I cannot fulfill your request for information about acceptance criteria and study results. The provided text is a letter from the FDA to a medical device company regarding the 510(k) clearance of "Powder Free Vinyl Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the following information that you requested:

• A table of acceptance criteria and reported device performance. The FDA letter is a regulatory approval, not a performance study report.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance. (This is not an AI/algorithm device).
• Type of ground truth used.
• Sample size for the training set.
• How ground truth was established for the training set.

The document only states the "Indication For Use" for the gloves, which is: "A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient."

To answer your request, I would need a different type of document, such as a clinical study report, a scientific publication, or a detailed technical submission to a regulatory body that specifically outlines performance testing and acceptance criteria for a medical device that would not be typical of examination gloves.

Ask a specific question about this device