(84 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Sterile Latex Examination Gloves (Powdered) with protein claim less than 100 µg/g
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, study details, or performance metrics for a device in the context of medical imaging or AI.
The document is a US FDA 510(k) clearance letter for "Sterile Examination Gloves (Powdered) with Protein Claim 100 Micrograms or Less." It discusses the regulatory classification, general controls, and substantial equivalence to a predicate device.
Therefore, I cannot provide a response to your request, as it pertains to a different type of medical device and study methodology than what is described in the provided text.
§ 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.