(24 days)
A pre-powdered patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Pre-Powdered Vinyl Non-sterile Examination Glove
I am sorry, but the provided text is an FDA 510(k) clearance letter and related documentation for "Pre-Powdered Vinyl Non-Sterile Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software device) meets such criteria. Instead, it is about the regulatory clearance of a physical medical glove.
Therefore, I cannot extract the requested information regarding AI device performance, sample sizes, ground truth, expert qualifications, or MRMC studies from this 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.