(75 days)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
Yellow, Red, Green, Black, Blue with Pearlescent™ Pigment, Powder-Free Nitrile Examination Gloves with Aloe Vera
The provided document is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. Therefore, I cannot generate the requested table and study description.
§ 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.