(157 days)
A patient exam glove is a disposable device intended to be worn on the examiner's hand to prevent contamination between patient and examiner.
Not Found
The provided documents are a 510(k) clearance letter from the FDA for medical gloves. This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of an AI/ML medical device.
The letter explicitly states that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The entire review focuses on regulatory compliance and substantial equivalence, not on the detailed performance characteristics or studies typically associated with AI/ML device evaluations.
Therefore, I cannot provide the requested information based on the input document.
To answer your request, I would need a document describing the testing and validation of an AI/ML medical device, which would typically include details such as clinical study protocols, performance metrics, and statistical analysis.
§ 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.