(43 days)
A 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.
Shanghai Giantmax Plastic Products Powder-Free Clear Vinyl Examination Glove
The provided document is a 510(k) premarket notification letter from the FDA regarding a sterile patient examination glove. This document does not contain information about a medical device that uses artificial intelligence (AI) and thus does not include acceptance criteria, study details, or performance metrics in the way your request describes for AI-enhanced devices.
The document essentially states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general controls and regulations but does not delve into specific performance studies with acceptance criteria as would be expected for a novel AI device.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study information for an AI device. The information provided in the document is for a traditional medical device (gloves) and does not align with the nature of your questions.
§ 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.