(81 days)
A patient Examination Glove 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.
Patient Nitrile Examination Glove (Powderfree)
This document is primarily a 510(k) clearance letter from the FDA for a "Patient Nitrile Examination Glove (Powderfree)". It states that the device is substantially equivalent to legally marketed predicate devices.
However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter is a regulatory approval notice, not a performance study report.
Therefore, I cannot extract the requested information from 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.