(43 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.
Prepowdered Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro)
This is a 510(k) premarket notification for disposable pre-powdered synthetic vinyl patient examination gloves. The provided documents do not contain information about acceptance criteria or a study with performance data for this device. The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include detailed performance testing results.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present 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.