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The Powder Free Latex Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves

This document is a marketing authorization letter from the FDA for a medical device (examination gloves). It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced diagnostic or AI-powered devices. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices, a regulatory pathway under 510(k).

Therefore, I cannot provide the requested information from this document. The document doesn't describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient & examiner.

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This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but this refers to regulatory equivalence based on intended use and technological characteristics, not performance against specific criteria.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document.

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This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.

NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE

The provided text is a 510(k) Pre-market Notification communication from the FDA to Asia Pacific Latex Berhad regarding Nitrile Patient Examination Gloves, Powder-Free. It is not a study or report on the performance of an AI/ML medical device. Therefore, I cannot provide the requested information as the document does not contain any details about acceptance criteria, device performance, study design, expert involvement, or ground truth for an AI/ML device.

The document is a regulatory approval letter for a physical medical device (gloves), confirming it is substantially equivalent to existing devices.

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