(75 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim; Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
The provided text is an FDA 510(k) clearance letter for a medical device: "Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim" and "Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim."
This document grants substantial equivalence based on the device's intended use as a patient examination glove, which is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner."
The FDA letter does not include information about AI/ML device performance, acceptance criteria, test set details, expert ground truth establishment, MRMC studies, or any of the other specific questions related to AI/ML device validation. These are standard requirements for AI/ML-driven medical devices, but this document pertains to a Class I medical device (gloves), which typically undergo different types of evaluation (e.g., biocompatibility, physical properties, sterility, and non-pyrogenicity) rather than AI/ML performance studies.
Therefore, it is not possible to extract the requested information from the provided text, as it describes the regulatory clearance for examination gloves, not an AI/ML powered device.
§ 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.