(86 days)
A Synthetic Vinyl Examination Gloves, powder free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Synthetic Vinyl Examination Gloves, Powder-Free
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification approval letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device that would typically involve such metrics (like an AI/ML powered device).
The information in the document pertains to regulatory approval for a physical medical device (gloves) and confirms its substantial equivalence to previously marketed predicate devices. It discusses general controls, regulations, and contact information, but not the kind of performance study details you are asking for.
§ 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.