(34 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.
Powdered Nitrile Examination Glove, White (Non-Colored)
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically "Powdered Nitrile Examination Glove, White (Non-Colored)". This type of document is about regulatory clearance for a device based on substantial equivalence to an existing predicate device, not about the results of a study demonstrating performance against specific acceptance criteria.
The information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is typically found in clinical trial reports, scientific publications, or specific sections of regulatory submissions (like a PMA, not a 510(k) for a Class I device like gloves). A 510(k) for a Class I device primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through basic performance testing (e.g., strength, barrier integrity) and comparison to the predicate's specifications, rather than a full-scale clinical comparative effectiveness study with human readers or AI.
Therefore, based solely on the provided text, I cannot extract the information required to fill out the requested table and answer the study-related questions. The document confirms the device's classification, acknowledges the date of submission and receipt, and states that the device is substantially equivalent to a predicate device. It does not contain detailed study results or explicit acceptance criteria for performance beyond regulatory compliance.
In summary, the provided document does not contain the information requested about acceptance criteria and a study proving the device meets those criteria.
§ 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.