(91 days)
Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
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This document is an FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves (Non sterile)". This type of medical device is a Class I device and does not involve AI/ML components for diagnosis or treatment. The content of this letter focuses on regulatory compliance for a physical product, not on the performance of a software algorithm.
Therefore, the requested information about acceptance criteria, study data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc., are not applicable to this document. These details are typically required for AI/ML-driven medical devices that output algorithmic decisions or analyses, not for physical examination gloves.
§ 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.