(53 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.
Barrier-Pro™ Co-polymer Patient Examination Glove, Powdered, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Methacrylic Acid Co-polymer Rubber (b)Barrier-Pro™ is a registered trade mark of Dow Reichhold Specialty Latex LLC
The provided text is a 510(k) premarket notification letter from the FDA regarding "Barrier-Pro™ Co-Polymer Patient Examination Gloves." This document does not contain information about the acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets those criteria.
Instead, this document is a regulatory approval for a physical medical device (patient examination gloves) based on substantial equivalence to a legally marketed predicate device.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set details) from this document as it pertains to a different type of medical device and regulatory review process.
§ 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.