(231 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Examination Powder Free Glove
The provided document is a 510(k) premarket notification letter from the FDA for a Vinyl Powder Free Examination Glove, which is a Class I medical device. This document does not contain any information regarding acceptance criteria, study details, or performance data for an AI/ML-based medical device.
Therefore, I cannot fulfill your request using the provided input. The document discusses regulatory aspects of a physical product (gloves) and not an AI-powered diagnostic or decision support system.
§ 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.