(30 days)
BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powder Free containing 50 ugm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of the examiner to prevent contamination between patient and examiner.
BRIGHTWAY™ Brand Blue Color Latex Examination Gloves, Powder Free containing 50 µgm or less of water extractable protein per gram.
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot provide the requested information. This document pertains to a medical device (latex examination gloves) and not an AI-powered device.
§ 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.