(154 days)
The Disposable Vinyl Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Disposable Vinyl Examination Gloves
The provided document is an FDA 510(k) clearance letter for "Disposable Vinyl Examination Gloves." This document does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria, as it pertains to medical gloves, not a diagnostic or AI-powered device.
The questions in the prompt are typical for evaluating a new diagnostic or AI-driven medical device submission, which would involve performance metrics like sensitivity, specificity, accuracy, and detailed study methodologies. This document is a regulatory clearance for a Class I medical device (non-powdered patient examination glove) which typically relies on established performance standards for physical properties rather than clinical performance studies described by the questions.
§ 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.