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The Powder Free Latex Examination Gloves, Sterile 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 Latex Examination Gloves, Sterile with Protein Content Labeling Claim is equivalent to the existing model, i.e. Comfit Sterile Latex Examination Gloves (Powder Free) which had submitted and cleared under 510(k) number K944141. The difference in this submission is: - To include Protein Content Labeling Claim statements on label, i.e. a) "This latex glove contains 50 micrograms or less of total water extractable protein per gram" and "Safe use of this glove by or on latex sensitised individuals has not been established". The device remains no change in product design and the additional claim does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections. The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 21 CFR 800.20.

This 510(k) summary describes a Powder Free Latex Examination Glove, Sterile with Protein Content Labeling Claim. The submission seeks to include protein content labeling claims on the existing device, which was previously cleared under 510(k) K944141. The core device design and intended use remain unchanged.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document indicates that the device "meets" the specified ASTM standards and FDA regulations, and provides specific values for Powder Residual and Protein Level. However, it does not explicitly state the sample size used for the tests to demonstrate compliance.

The provenance of the data is not specified (e.g., country of origin, retrospective/prospective). It is implied that the testing was conducted by or on behalf of WRP Asia Pacific Sdn Bhd.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical glove and its performance is evaluated against material and physical property standards, not through expert-driven clinical assessment or interpretation.

4. Adjudication method for the test set

Not applicable. The evaluation is based on objective measurements against established ASTM and FDA standards for material and physical properties, not subjective assessment requiring adjudication.

5. 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; it is not an AI-powered diagnostic or assistive technology for human readers.

6. 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. The "standalone" performance here refers to the device's ability to meet physical and chemical standards independently. The reported performance is a standalone assessment of the glove's properties.

7. The type of ground truth used

The ground truth used is established by recognized ASTM (American Society for Testing and Materials) standards and FDA (Food and Drug Administration) regulations. These standards define the acceptable specifications and test methods for physical properties (dimensions, physical properties, freedom from pinholes), chemical properties (powder residual), and protein content in examination gloves.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of medical device.

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