(15 days)
A medical glove is wom on the hand of healtheare and similar personnel to prevent contantination between healtheare personnel and patient.
Powdered Synthetic Vinyl Patient Examination Gloves, White
The provided text is a 510(k) premarket notification decision letter from the FDA for a medical device (Powdered Synthetic Vinyl Patient Examination Glove).
This document focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way that would typically be found in a clinical trial report or a performance validation study for an AI/ML device.
Therefore, I cannot provide the requested information, particularly items 1 through 9, as they pertain to detailed performance studies which are not present in this regulatory letter.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This indicates the approval is based on a comparison to existing devices, not a new clinical performance study as might be conducted for novel AI/ML diagnostics.
§ 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.