(114 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.
Powdered Latex Examination Gloves Contains 200 microgram or less of total water Extractable Protein per gram
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powdered Latex Examination Gloves." This document does not contain information about software as a medical device (SaMD), AI/ML, or the specific types of studies, metrics, and acceptance criteria normally associated with such devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document pertains to a physical medical device (gloves) and its regulatory clearance based on substantial equivalence to predicate devices, not performance metrics derived from a study comparing algorithms or human readers.
§ 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.