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A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the examiner's hand or finger's for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder

The provided text is an FDA 510(k) clearance letter for "Ever-More Powder-Free Latex Examination Gloves" and an "Indication For Use" statement. This document primarily focuses on regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

It does not contain any information about a study that assesses the performance of a device against specific acceptance criteria in the way you've described (e.g., using a test set, ground truth, expert adjudication, or AI performance metrics).

Therefore, I cannot provide the requested information. The document is about a regulatory clearance, not a performance study report.

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A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the examiner's hand or finger's for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Powder-Free Latex Examination Gloves - Blue Color

This document is a 510(k) premarket notification letter from the FDA regarding "Ever-More Powder-Free Latex Examination Gloves-Blue Color." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The letter does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Ask a specific question about this device