(50 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.
Powder-free Nitrile Patient Examination Glove (Blue /Green)
This looks like a 510(k) clearance letter for medical gloves, not a report about a diagnostic device or AI algorithm. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable to the provided document.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than meeting specific performance criteria through a detailed study as would be expected for a novel diagnostic device or AI.
§ 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.