(51 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 Powdered Vinyl Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powdered Vinyl Examination Gloves". This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel AI/ML-driven diagnostic device.
Therefore, the specific information requested in the prompt about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this document. The FDA's determination for this device is based on demonstrating substantial equivalence to a predicate device, as outlined in the letter, rather than a clinical study with detailed performance metrics as would be required for an AI/ML diagnostic.
§ 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.