(61 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Black and Gray Color
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Black and Gray Color". This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth for AI/device performance.
The letter confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to legally marketed predicate devices. It lists regulations and requirements that the manufacturer must comply with, but it does not detail the technical performance criteria or the studies used to demonstrate that performance.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document is a regulatory approval letter, not a performance report.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. This type of study is not relevant for basic examination gloves.
- If a standalone performance study was done: Not present in this document.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
This document serves as an FDA clearance for a medical device (examination gloves) based on substantial equivalence, and it does not delve into the detailed performance metrics or study methodologies typically associated with software as a medical device (SaMD) or AI-based devices.
§ 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.