(70 days)
A powderfree patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Sunmax Blue Nitrile Powderfree Examination Glove
This document is a 510(k) premarket notification from Sunmax Enterprises Shanghai Company Limited for their Sunmax Blue Nitrile Powder Free Examination Glove. The FDA has found the device substantially equivalent to legally marketed predicate devices.
The document does not detail specific acceptance criteria or a study that proves the device meets those criteria in the way envisioned by the request. Instead, it indicates that the device has been deemed "substantially equivalent" to predicate devices already on the market. In the context of a 510(k) submission for this type of medical device (examination gloves), substantial equivalence is typically established by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that it does not raise new questions of safety and effectiveness and is as safe and effective as the predicate.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment, which are common for higher-risk devices or more complex software/AI-based medical devices, are not explicitly present or applicable in this 510(k) for an examination glove.
However, based on general FDA requirements for examination gloves and the information provided, we can infer some aspects:
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A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of acceptance criteria for performance like accuracy, sensitivity, or specificity. For examination gloves, acceptance criteria usually relate to physical properties and barrier integrity. These would typically include:Acceptance Criterion (Inferred) Reported Device Performance (Inferred) Barrier Integrity (e.g., AQL for pinholes) Passed (implied by substantial equivalence) Tensile Strength Met (implied by substantial equivalence) Elongation Met (implied by substantial equivalence) Dimensions Met (implied by substantial equivalence) Biocompatibility (skin irritation, sensitization) Met (implied by substantial equivalence) Powder-free status Met (as per device name "Powder Free") The "reported device performance" is not explicitly stated but is implied to meet the necessary standards for substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance: There is no specific test set sample size or data provenance mentioned in this document. For gloves, testing is typically done on batches, and the FDA would evaluate manufacturing controls, not a clinical trial with a "test set" in the AI or diagnostic sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For examination gloves, performance is assessed through standardized physical and chemical tests, not through expert-established ground truth on a test set.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an examination glove, not an AI or diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be laboratory measurements and adherence to recognized standards (e.g., ASTM standards for medical gloves) and FDA guidance for physical properties, rather than diagnostic outcomes.
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The sample size for the training set: Not applicable. This is not a machine learning device.
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How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) letter confirms the regulatory clearance based on substantial equivalence, rather than detailing a specific performance study with acceptance criteria in the manner requested for complex diagnostic or AI devices. The information provided is typical for a Class I medical device like an examination glove.
§ 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.