(31 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green and White color.
The provided document is an FDA 510(k) Pre-market Notification letter for Polymer Coated Powder Free Nitrile Examination Gloves. This type of document is a regulatory approval and does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based medical device.
The questions you've asked are typical for studies evaluating the performance of algorithms or diagnostic devices (often involving AI/ML), where there's a need to establish sensitivity, specificity, accuracy, and compare to a ground truth established by experts.
This document, however, pertains to a physical medical device (examination gloves) and focuses on substantial equivalence to a predicate device, as per the FDA 510(k) process for Class I devices. The "performance" for such a device is typically assessed through physical properties and safety standards, rather than diagnostic accuracy metrics.
Therefore, I cannot extract the requested information from 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.