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Brightway™ Brand Latex Examination Glove, Powdered is a disposable patient examination glove which contains 150 µgm or less of total extractable protein per gram, that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Brightway™ Brand Latex Examination Gloves, Powdered with 150 ugm or less of total water extractable protein per gram

The provided text is a 510(k) premarket notification letter from the FDA to Brightway Holdings Sdn. Bhd. regarding their Brightway™ Brand Latex Powdered Examination Glove. This document is a regulatory approval letter and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical study report or a technical performance evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document states that the device is "substantially equivalent" to predicate devices, meaning it has been determined to be as safe and effective as a device already legally marketed. This determination is based on the information provided in the 510(k) submission, which would have included performance data, but that data is not detailed in this approval letter.

The relevant information from the document is:

• Device: Brightway™ Brand Latex Powdered Examination Glove (Contains 150 Mcgm or Less of Total Water Extractable Protein Per Gram)
• Regulatory Class: I
• Product Code: LYY
• Indications for Use: "Brightway™ Brand Latex Examination Glove, Powdered is a disposable patient examination glove which contains 150 µgm or less of total extractable protein per gram, that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner."

To answer the questions posed, one would need to refer to the actual 510(k) submission (K990540) itself, which would contain the technical data and studies conducted to demonstrate substantial equivalence.

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