(66 days)
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Disposable Medical Nitrile Examination Gloves
The provided FDA 510(k) clearance letter (K213912) is for "Disposable Medical Nitrile Examination Gloves." This document does not describe a software device or an AI/ML algorithm. Instead, it concerns a physical medical device.
Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details cannot be extracted from this document as it pertains to a different type of medical device altogether.
The document confirms the substantial equivalence of the gloves to a predicate device and outlines general regulatory obligations for the manufacturer. It does not contain any performance metrics or study designs related to AI/ML or diagnostic accuracy.
§ 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.