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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.

The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.

The device in question is the "Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling)", which is a patient examination glove.

Acceptance Criteria and Device Performance:

The acceptance criteria for the glove are based on established ASTM standards and FDA regulations. The device's performance is reported to meet all these criteria.

Study Information:

For this type of medical device (patient examination glove), the submission explicitly states that clinical data is not needed. The assessment of device performance relies on non-clinical performance data, which includes the physical and chemical tests outlined in the table above.

Given that no clinical study was conducted or required:

1. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The performance is based on laboratory testing against standards for characteristics like dimensions, physical properties, pinholes, powder content, and protein level. These tests are typically performed on samples from manufacturing batches. The data provenance would be from manufacturing and testing facilities in Malaysia (country of origin for the submitter).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and chemical tests is established by adhering to widely accepted ASTM standards and laboratory protocols, not by expert consensus in a clinical setting.
3. Adjudication method for the test set: Not applicable, as there was no clinical test set requiring adjudication. Laboratory test results are compared directly against the specified standards.
4. 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 physical medical glove, not an AI-powered diagnostic or assistive tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used: For the physical and chemical properties, the "ground truth" is defined by the objective measurements and parameters set forth in the ASTM standards (e.g., specific tensile strength values, elongation percentages, maximum allowable pinholes per unit, maximum powder/protein content). For biocompatibility, the ground truth is established by the observed biological response in animal models (absence of primary skin irritation or contact sensitization).
7. The sample size for the training set: Not applicable, as no algorithm or AI model was involved that would require a training set.
8. How the ground truth for the training set was established: Not applicable.

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