(227 days)
A Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves Contains 50 microgram or less of total water Extractable Protein per gram
This document is a 510(k) premarket notification for "Powder Free Latex Examination Gloves" and does not contain information about the acceptance criteria and study proving a device meets those criteria. The document is for a medical device (gloves), which typically undergo different types of testing (e.g., integrity, biocompatibility, dimensions) rather than the type of performance study with "ground truth" and "expert readers" that your questions imply for AI-powered diagnostic devices.
Therefore, I cannot provide the requested information based on the input 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.