(70 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Disposable Powder Free Vinyl Exam Glove, Blue Color
The provided documents are an FDA 510(k) clearance letter for a Disposable Powder Free Vinyl Exam Glove. This type of document does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging diagnostics.
The FDA 510(k) clearance process for a patient examination glove primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, assessing characteristics like material safety, freedom from pinholes, and tensile strength, rather than diagnostic accuracy or AI performance.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from these documents as they are irrelevant to such a request.
§ 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.