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Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.

Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange)

The provided text is a 510(k) premarket notification letter from the FDA to Brightway Holdings Sdn. Bhd. for "Brightway Brand Colored Powder Free Nitrile Examination Gloves, Orange". This document approves the device for market based on substantial equivalence to a predicate device.

It does NOT contain the type of acceptance criteria, study details, or performance data typically found for AI/ML-based medical devices. The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA) or extensive clinical trials as would be the case for novel AI.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This information is simply not present in the provided text.

The document discusses regulatory classification (Class I), general controls, and compliance requirements, but not the technical performance metrics of the gloves themselves.

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