(30 days)
BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powdered containing 150 ugm or less of water extractable protein per grain is a usposable passimilar personnel to prevent contamination between patient and examiner.
BRIGHTWAY™ Brand Blue Color Latex Examination Gloves, Powdered containing 150 μgm or less of water extractable protein per gram.
This document is a 510(k) clearance letter from the FDA for a medical device: "BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powdered."
It does not contain information related to acceptance criteria, device performance studies, sample sizes, expert involvement, or any other details typically associated with the evaluation of a device's effectiveness or safety through clinical or performance studies that would use such metrics.
Instead, this letter confirms that the device has been found "substantially equivalent" to predicate devices already on the market, meaning it has the same intended use and technological characteristics as a legally marketed device or, if there are differences, those differences do not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information from the provided text.
§ 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.