(45 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.
Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)
The provided text is a 510(k) premarket notification letter from the FDA regarding "Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)". It confirms that the device is substantially equivalent to a legally marketed predicate device.
This document does not contain information about acceptance criteria or a study proving device performance against acceptance criteria for an AI-powered medical device.
Instead, it's a regulatory approval document for a physical medical device (gloves), indicating that it meets the requirements for a Class I device and can be marketed based on substantial equivalence.
Therefore, I cannot provide the requested information in the format of acceptance criteria and study details for an AI device. The document is about a different type of medical product and regulatory process.
§ 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.