(66 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Vinyl Synthetic Exam Gloves, Powder Free." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving a device's performance in the context of AI, medical imaging, or diagnostic accuracy.
The device in question is a pair of examination gloves, and the approval is based on substantial equivalence to a predicate device, not on a performance study comparing the device to specific acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria or a performance study from this document. The questions posed are related to the evaluation of AI/software as a medical device, which is not applicable to the product described in 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.