(44 days)
The Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water extractable protein per gram of 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.
Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water soluble protein per gram of glove)
I am sorry, but the provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Non-Sterile, Powder Free, Black Latex Exam Gloves with Protein Labeling Claim."
The letter discusses the substantial equivalence determination for the gloves and states that the device meets the general controls provisions of the Act. It also mentions a protein labeling claim of "50 micrograms or less of total water soluble protein per gram of glove." However, it does not describe specific acceptance criteria in a table, nor does it detail a study performed to demonstrate meeting those criteria using the requested information points (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details, etc.).
Therefore, I cannot provide the requested information based on the given text.
§ 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.