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The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.

The provided document describes the acceptance criteria and performance of the WRP Asia Pacific Sdn Bhd "Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim)". Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for testing each characteristic. The data provenance is prospective as it's a submission for a new device claiming equivalence to existing standards. The manufacturer is WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, MALAYSIA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The general nature of the tests (meeting ASTM standards) suggests laboratory testing rather than expert-based ground truth establishment for a medical device that does not involve imaging or complex diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not provided as the tests are objective laboratory measurements against defined standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or AI-assisted interpretation devices, which is not applicable to surgical gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

N/A. This device is a physical medical device (surgical gloves), not an algorithm or software. Therefore, the concept of "standalone performance" in this context is not applicable.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device performance is based on established industry standards and regulatory requirements, specifically:

• ASTM International (formerly American Society for Testing and Materials) standards (e.g., D 3577-00, D 6124-00, D 5712-95).
• FDA regulations (21 CFR 800.20).
• Biological tests (Primary Skin Irritation in Rabbits, Dermal Sensitization).

These standards define the acceptable range or threshold for each characteristic, forming the ground truth against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable/not provided. For a physical medical device like surgical gloves, there isn't a "training set" in the same sense as for an AI/ML algorithm. The manufacturing process is controlled to ensure consistent product characteristics that meet the specified standards.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As mentioned above, there isn't a "training set" for surgical gloves. The "ground truth" for the device's characteristics is established by the specified ASTM standards and FDA regulations, which were developed through scientific research, consensus, and regulatory processes over time. The manufacturer demonstrates that its production meets these pre-established standards.

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