(36 days)
A patient examination glove is a disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between patient and examiners.
Nitrile Patient Examination Gloves - Powder Free Blue and White Color
The provided text is a 510(k) clearance letter from the FDA for "Nitrile Examination Gloves - Powderfree" and an "Indication for Use" statement. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the request.
Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval, not a scientific study report.
§ 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.