(78 days)
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
Polymer Coated Powder-Free Latex Examination Gloves
The provided FDA document is a 510(k) clearance letter for "Polymer Coated Powder-Free Latex Examination Gloves" (K990690). This document is an approval for a medical device and not a study report for a diagnostic AI device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and study details for an AI-powered device.
Specifically, the document:
- Does not describe any AI device. It's for a physical product (gloves).
- Does not present acceptance criteria in the context of an algorithm's performance (e.g., sensitivity, specificity).
- Does not include any study data relating to algorithm performance, sample sizes, ground truth, or expert review.
- Does not mention multi-reader multi-case studies or standalone algorithm performance.
Therefore, I cannot extract the requested information from the provided 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.