(808 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.
Nitrile Patient Examination Powder Free Glove, Textured, Black
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Nitrile Patient Examination Powder Free Glove, Textured, Black" does not contain the information requested in your prompt regarding acceptance criteria and performance study details for a medical device that uses AI or goes through a rigorous testing process like that.
This document is a clearance letter for a Class I medical device (patient examination glove), which is a very low-risk device. The FDA's review process for such devices typically focuses on ensuring they are substantially equivalent to existing predicate devices and meet general controls (like manufacturing quality, labeling, etc.). It does not involve complex performance studies with AI, human readers, or ground truth establishment as would be required for higher-risk or AI-powered devices.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance: This document doesn't define quantitative performance criteria or report on specific performance metrics for the glove.
- Sample size used for the test set and data provenance: No such testing is described for a glove.
- Number of experts and qualifications for ground truth: Not applicable to this type of device.
- Adjudication method for the test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no AI training involved).
- How ground truth for the training set was established: Not applicable.
The document primarily states that the device is "substantially equivalent" to a legally marketed predicate device and outlines general regulatory obligations for the manufacturer.
§ 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.