(104 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
I am sorry, but this document is an FDA clearance letter for a medical device (Powder Free Latex Patient Examination Glove), not a study report for a device that utilizes Artificial Intelligence or Machine Learning. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and performance studies for an AI/ML device.
The document discusses regulatory information, indications for use for a glove, and administrative details, but there is no mention of an algorithm, AI, or any associated performance metrics typically found in studies for such devices.
§ 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.