(150 days)
A 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.
Comfort Powderfree Latex Examination Glove with Latex ("Powder-free") 80LYY Protein Content Labeling Claim (50 micrograms or less)
The provided document is a 510(k) premarket notification letter from the FDA regarding "Comfort Powder-Free Latex Examination Gloves." This document grants substantial equivalence to a medical device, which is a regulatory approval, not a scientific study describing acceptance criteria and device performance based on a study.
Therefore, the document does not contain any of the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), or training set information. The document solely focuses on regulatory approval based on substantial equivalence to a predicate 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.