(84 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 examiners.
Multi-ply Powder-free Latex Examination Gloves with Protein content labeling claim(50ug/g or less total water extratable protein content)
This is a 510(k) premarket notification letter from the FDA regarding "Multi-Ply Powder-Free Latex Examination Gloves With Protein Content Labeling Claim (50ug/g Or Less Total Water Extractable)". It is a regulatory approval document and does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates a "substantial equivalence" determination, not a study demonstrating performance against specific acceptance criteria in the way a clinical or AI performance study would.
Therefore, I cannot provide the requested information based on the provided 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.