(46 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)
This document is a 510(k) premarket notification letter from the FDA regarding "Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)". It indicates that the device has been determined to be substantially equivalent to previously marketed devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The provided text is a regulatory notification, not a technical report detailing device performance studies.
§ 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.