(16 days)
A 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.
Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
The provided text describes a 510(k) premarket notification for "Nitrile Powder-Free Examination Gloves" by Allegiance Healthcare Corporation. It is a submission for a medical device that does not involve AI or algorithms, and therefore, many of the requested categories are not applicable.
Here's the information based on the provided text, indicating "N/A" (Not Applicable) for categories that pertain to AI/algorithm-based devices:
Acceptance Criteria and Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No irritation | Gloves show no irritation. |
| Guinea Pig Maximization | No potential for irritation | Gloves do not display any potential for irritation. |
| Tensile Strength | Meet or exceed requirements per ASTM D6319-00a | Gloves meet or exceed requirements per ASTM D6319-00a. |
| Barrier Defects | Meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a | Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a. |
Study Details
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Sample size used for the test set and the data provenance: Not specified, as this is a physical device rather than an AI/data-driven one. The tests are for physical properties and biocompatibility.
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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. Ground truth for physical properties and biocompatibility tests would be established through standardized testing protocols executed by designated laboratory personnel, not clinical experts for ground truth in the AI sense.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The tests involve objective measurements and observations against established standards, not interpretation requiring adjudication.
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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, as this is not an AI-assisted device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. For example:
- Biocompatibility tests (Skin Irritation, Guinea Pig Maximization): "No irritation" or "no potential for irritation" as determined by standardized biological evaluation methods.
- Tensile Strength: Measurements meeting specified values in ASTM D6319-00a.
- Barrier Defects: Compliance with defect limits set in 21 CFR §800.20 and ASTM D6319-00a.
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The sample size for the training set: Not applicable, as there is no training set for a physical device like examination gloves.
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How the ground truth for the training set was established: Not applicable.
§ 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.