(46 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Blue Nitrile Examination Gloves (Polymer Coated)
This document is a 510(k) clearance letter from the FDA for "Powderfree Blue Nitrile Examination Gloves (Polymer Coated)". It does not describe a study that proves the device meets acceptance criteria in the manner requested (e.g., performance metrics like accuracy, sensitivity, specificity, etc., with associated ground truth, expert review, or sample sizes) for an AI/software as a medical device.
The FDA's 510(k) clearance process for this type of device (medical gloves) focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the specific information requested in the format of acceptance criteria and study details for an AI/software device. The document does not contain:
- A table of acceptance criteria and reported device performance: This document does not present performance data like accuracy, sensitivity, or specificity. For gloves, acceptance criteria would typically relate to physical properties (e.g., tensile strength, elongation, puncture resistance) and barrier integrity (e.g., AQL for pinholes), which are not detailed here. The "reported device performance" section is thus not applicable in the context of this document.
- Sample sizes, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or ground truth types for a test set: These are all concepts relevant to performance studies for AI/software devices. This document only states that the device is "substantially equivalent" to predicate devices, implying that its safety and effectiveness are comparable, not that a specific performance study in the AI/software context was conducted.
- Sample size for the training set and how ground truth was established for the training set: These are also concepts for AI/software development and are not part of a 510(k) for medical gloves.
In summary, the provided document is a regulatory clearance for a physical medical device (examination gloves) based on substantial equivalence, not a technical report detailing a performance study for an AI or software device. As such, the specific information requested about acceptance criteria and study details (especially those related to AI/software performance) cannot be extracted from this document.
§ 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.