(72 days)
A patient examination Vinyl Powder Free Examination Clove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent intended for medical purpose th intended for medical purpose and examiner.
Vinyl Powder Free Examination Glove
The provided document is a 510(k) premarket notification letter for a Vinyl Powder Free Examination Glove. This document pertains to the regulatory approval of a medical device (a glove), not an AI/ML powered device. As such, it does not include information on acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.
Therefore, I cannot provide the requested information based on this document.
§ 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.