(35 days)
A patient examination gloves 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.
Disposable Powder Free Vinyl Patient Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powder Free Vinyl Patient Examination Gloves." It is not a study report or clinical trial document for a diagnostic AI device. Therefore, it does not contain the information required to answer your request regarding acceptance criteria, study details, ground truth, or sample sizes related to an AI device.
The document discusses the substantial equivalence of the gloves to previously marketed predicate devices under the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
To answer your questions, I would need a document that describes a study performed on a medical AI device.
§ 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.