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

Powdered Vinyl Examination Gloves

I am sorry, but based on the provided document, there is no information about the acceptance criteria or a study proving the device meets those criteria.

This document is a 510(k) clearance letter from the FDA for "Powdered Vinyl Examination Gloves" manufactured by Shijiazhuang Brethren Plastic Company, Limited. It indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

The letter discusses regulatory aspects like general controls, GMP compliance, and labeling, and includes an "Indication For Use Statement." However, it does not contain:

1. A table of acceptance criteria or reported device performance.
2. Details about sample size, data provenance, or ground truth establishment for a test set.
3. Information on expert involvement or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
5. Information on a training set or how its ground truth was established.

The document's purpose is to grant market clearance based on substantial equivalence, not to detail the specific performance testing data that supported that equivalence.

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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