(83 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Yellow Synthetic Vinyl Patient Examination Gloves
The provided document is a 510(k) clearance letter from the FDA for "Powdered Yellow Synthetic Vinyl Patient Examination Gloves." It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Instead, the document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but those characteristics do not raise new questions of safety and effectiveness and are shown to be at least as safe and effective as the predicate device.
Therefore, I cannot answer the request as the necessary information for acceptance criteria and a study proving the device meets them 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.