(41 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.
Powdered Patient Nitrile Examination Gloves (Blue Colour)
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powdered Nitrile Examination Gloves (Blue Colour)". It confirms that the device is substantially equivalent to legally marketed predicate devices.
**This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details for an AI/ML powered device. **
The letter is a regulatory approval for a physical medical device (gloves), not an AI/ML software device, and therefore the requested information is not applicable to its contents.
§ 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.