(41 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
This request cannot be fulfilled as the provided text is a 510(k) clearance letter for patient examination gloves. This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the AI/ML device context described in the request. The letter is a regulatory compliance document for a physical medical device (gloves), not an AI/ML algorithm.
§ 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.