(116 days)
mCare® Powder Free Nitrile Black Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
mCare® Powder Free Nitrile Black Examination Glove
The provided text is a U.S. FDA 510(k) clearance letter for the mCare® Powder Free Nitrile Black Examination Glove. It is a regulatory document affirming substantial equivalence to a predicate device and discussing compliance requirements for marketing this Class I medical device. It is not a study report for a medical device that uses AI or complex algorithms, nor does it contain information about acceptance criteria or performance studies of such a device.
Therefore, I cannot provide the requested information because the document does not contain details about:
- Acceptance criteria table and reported device performance for an AI/algorithmic device.
- Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for ground truth establishment.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Training set sample size or ground truth establishment for a training set.
The document discusses the regulatory classification of a glove and its intended use, which is a simple barrier 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.