(54 days)
BRIGHTWAY™ Brand Latex Examination Glove ( Powder Free, Black Color ) containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
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This document is a 510(k) premarket notification letter from the FDA regarding "BRIGHTWAY™ Brand Latex Examination Gloves (Power Free, Black Color) Containing 50 ug or Less of water Extractable Protein Per Gram". It details the FDA's determination of substantial equivalence to legally marketed predicate devices.
However, the provided text does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, expert ground truth establishment, or any details about a study and its methodology as requested in your prompt. The document is an administrative approval letter, not a scientific study report.
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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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 and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.