(7 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and protein claim (50 micrograms or less).
The provided document is a 510(k) summary for non-sterile, powder-free latex examination gloves. It does not describe an AI/ML powered medical device, nor does it contain information about a study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods for an AI/ML device.
Instead, this document is concerned with demonstrating substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794) for regulatory purposes. The comparison table confirms that the new device has "Identical" or "Similar" characteristics to the predicate device across various technological aspects.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as this document is not about such a 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.