(46 days)
BRIGHTWAY™ Brand Latex Examination Glove, Powder Free 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.
Not Found
This document is a 510(k) premarket notification approval letter for "Brightway™ Brand Latex Examination Gloves Powder-Free." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a regulatory approval document rather than a study report.
Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
§ 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.