(63 days)
A patient examination glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA to a manufacturer of disposable powder-free vinyl examination gloves. It states that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information about acceptance criteria, device performance studies, or ground truth establishment for an AI/device. It is a regulatory approval letter for a simple medical device (gloves) and does not involve AI or complex performance metrics beyond basic safety and effectiveness for its intended use (preventing contamination).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.
§ 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.