(48 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50 MICROGRAMS OR LESS
The provided text is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim of 50 micrograms or less)." This type of document does not typically contain acceptance criteria or study details in the way a clinical study report or a technical design document for a complex medical device (like an AI algorithm) would.
A 510(k) clearance is based on demonstrating "substantial equivalence" to a predicate device already on the market. This often involves showing that the new device meets recognized standards, performs similarly in basic tests, and has the same intended use and technological characteristics as the predicate. The focus is usually on manufacturing, material conformity, and basic performance parameters relevant to the device's function (e.g., barrier integrity for gloves), rather than complex diagnostic accuracy studies.
Therefore, many of the requested categories for acceptance criteria and study information will not be directly available or applicable from this specific document.
However, I can extract what is implied or stated (even if it's minimal) and indicate where information is missing or not relevant for this type of device and document.
Implied Acceptance Criteria and Performance (Based on Device Type and Clearance Letter):
The core "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing legally marketed devices.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implied) | Reported Device Performance (Implied from Clearance) |
|---|---|
| Material: Powderfree Latex | Met (Device name specifies "Powderfree Latex") |
| Coating: Polymer Coated | Met (Device name specifies "Polymer Coated") |
| Protein Level: ≤ 50 micrograms/gram of glove | Met (Device name specifies "Protein Label Claim of 50 micrograms or less") |
| Intended Use: Patient Examination Glove (disposable, prevents contamination) | Met (Indicated Use matches predicate devices) |
| Performance: Substantially equivalent to predicate | Deemed substantially equivalent by FDA |
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Sample size used for the test set and the data provenance:
- Not specified in this document. For gloves, testing would typically involve batches of manufactured gloves to assess properties like tensile strength, elongation, barrier integrity (e.g., freedom from pinholes), and protein levels. This would likely be internal testing by the manufacturer.
- Provenance: This would be generated by the manufacturer, likely from their production batches. Country of origin for testing is not stated, but the manufacturer is based in Malaysia.
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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/specified for this type of device. "Ground truth" in the context of examination gloves isn't established by expert consensus on diagnoses. It's established by laboratory testing against recognized standards (e.g., ASTM standards for medical gloves) for physical properties and chemical composition. The "experts" would be laboratory technicians or engineers qualified to perform such tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for objective laboratory testing of glove properties.
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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 is a medical glove, not an AI-powered diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical glove, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device would be established by objective laboratory measurements of physical properties (e.g., barrier integrity, tensile strength, elongation) and chemical analysis (e.g., protein content) in accordance with relevant national or international standards (e.g., FDA guidance documents, ASTM standards).
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The sample size for the training set:
- Not applicable. This is not a machine learning/AI device. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary, the provided document is an FDA clearance letter for a low-risk medical device (examination gloves), which is fundamentally different from devices that would require complex clinical trials, AI algorithm validation, or expert consensus "ground truth" studies. The "study" for this device would involve internal validation testing by the manufacturer to ensure the gloves meet specifications and recognized standards, which FDA reviews for substantial equivalence to a predicate device.
§ 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.