(200 days)
The Powder Free Nitrile Examination Gloves(White, Cobalt Blue) 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.
Powder Free Nitrile Examination Gloves(White, Cobalt Blue, Blue and Violet Blue)
I am sorry, but the provided text from the FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves" does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/medical imaging perspective.
The document is purely a regulatory clearance letter for a Class I medical device (disposable examination gloves), stating that the device is substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and administrative aspects of FDA clearance, but not the technical performance or validation studies typical for AI-based medical devices.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This document does not specify performance criteria or results for the gloves beyond their intended use as a barrier.
- Sample size used for the test set and the data provenance: Not applicable to examination gloves.
- Number of experts used to establish the ground truth and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Stand-alone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
To answer your request, I would need a document detailing the validation of an AI/imaging device, which this 510(k) letter is not.
§ 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.