(39 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Powder-Free Synthetic Vinyl Exam Gloves with Vitamin E coating
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, based on the information available:
Device: Powder-Free Synthetic Vinyl Exam Gloves With Vitamin E Coating
Acceptance Criteria and Device Performance:
The provided document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a legally marketed predicate device. For this type of device (patient examination gloves), the primary acceptance criteria revolve around performance standards related to integrity (preventing contamination) and biocompatibility, rather than diagnostic accuracy or specific clinical outcomes often seen with AI/clinical decision support devices.
While the document doesn't explicitly list a table of acceptance criteria with reported device performance, it implies that the device has met the necessary standards for patient examination gloves to be deemed substantially equivalent. Key aspects for such gloves typically include:
- Barrier Protection (Freedom from Holes): Measured by acceptable quality levels (AQL) from water leak tests.
- Physical Properties: Tensile strength, elongation, etc., to ensure durability during use.
- Biocompatibility: Absence of adverse reactions upon skin contact.
- Powder-Free Status: Compliance with industry standards for powder residue.
- Vitamin E Coating Specificity: Given the "With Vitamin E Coating" in the name, there would likely be requirements or characterization related to the presence and safety of this coating, potentially contributing to skin conditioning or reducing irritation. The FDA's acceptance suggests these aspects were found to be compliant.
Since no specific study results or performance metrics are detailed in the provided text, the table below reflects what would typically be expected for this type of device to meet FDA acceptance for 510(k) clearance, rather than explicitly stated metrics from the document.
| Acceptance Criteria (Typical for Exam Gloves) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Freedom from holes (e.g., AQL 2.5 for critical defects) | Meets or exceeds industry standard for barrier integrity |
| Tensile Strength (e.g., Min 14 MPa) | Meets or exceeds industry standard for physical durability |
| Elongation at Break (e.g., Min 300%) | Meets or exceeds industry standard for flexibility |
| Biocompatibility (e.g., primary skin irritation, dermal sensitization) | Biocompatible with skin contact |
| Powder Residue (e.g., Max 2 mg per glove) | Meets industry standard for powder-free classification |
| Vitamin E Coating Presence/Safety | Present and safe for intended use |
Other Requested Information based on the provided document:
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Sample size used for the test set and the data provenance: The document does not provide details about sample sizes for testing or data provenance (e.g., country of origin, retrospective/prospective). This information would typically be in the 510(k) submission itself, not the FDA clearance letter.
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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 or provided. For patient examination gloves, "ground truth" typically refers to objective material and performance standards, not expert clinical interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided. Adjudication methods are relevant for subjective assessments, typically in diagnostic or screening device studies.
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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 a medical glove, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" would be established by objective engineering standards and laboratory test results (e.g., water leak test for pinholes, tensile strength measurements, biocompatibility assays) rather than expert consensus, pathology, or outcomes data.
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The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
Conclusion from the Document:
The provided FDA letter (K051683) indicates that Shen Wei (USA), Incorporated's Powder-Free Synthetic Vinyl Exam Gloves With Vitamin E Coating has been found substantially equivalent to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a device already on the market, based on the information provided in the 510(k) submission, implied to include sufficient testing against established performance standards for patient examination gloves. The letter itself does not contain the detailed study results or specific acceptance criteria, but rather the regulatory outcome of their review.
§ 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.