(420 days)
Powder Free Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Vinyl Examination Glove
This document is a 510(k) clearance letter for a "Powder Free Vinyl Examination Glove". It does not contain information about the acceptance criteria or a study that proves the device meets such criteria in the way typically associated with AI/ML-driven medical devices.
The document states that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices. This determination is based on the device meeting the same indications for use and having similar technological characteristics, not necessarily through rigorous performance studies comparing it against predefined acceptance criteria for complex diagnostic tasks.
Therefore, I cannot provide the requested information for the following reasons:
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No Acceptance Criteria Table: The document does not define specific performance metrics, thresholds, or an acceptance criteria table for the glove. The substantial equivalence determination for this type of device (a patient examination glove) focuses on material safety, performance standards (like barrier integrity, tensile strength), and indications for use, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC.
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No Performance Study Description: The document does not describe a clinical or algorithmic performance study with a test set, ground truth, expert review, or statistical measurements. The evaluation for examination gloves typically involves bench testing for physical properties and biocompatibility, not analysis of diagnostic accuracy.
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No AI/ML Component: The device is a physical examination glove, not an AI or ML-driven software device. Therefore, questions regarding:
- Sample size for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth (for diagnostic purposes)
- Training set size and ground truth establishment
are not applicable to this device.
In summary, this document is an FDA clearance for a medical device (examination glove) based on substantial equivalence, which is a different regulatory pathway and evaluation process compared to the one typically involving detailed performance studies with acceptance criteria for AI/ML 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.