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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 Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577-0151 and FDA 21 CFR 800.20.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, dimensions, etc.). It refers to meeting the requirements of the listed ASTM and FDA standards, which would imply that the sample sizes and methodologies prescribed by those standards were followed.

Data provenance is not explicitly stated beyond the fact that the company is WRP Asia Pacific Sdn Bhd, based in Malaysia. The testing would have been done by or for this manufacturer. The data is retrospective relative to the submission date.

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

This information is not provided. The tests are based on established ASTM and FDA standards for medical device performance, which define the testing methodologies and criteria rather than relying on expert consensus for each test. For example, a "freedom from pinholes" test would involve a standardized water leak test, not an expert visual assessment.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI/diagnostic imaging devices where human readers are interpreting data. This document describes a physical medical device (surgical gloves), and its performance is evaluated against physical and chemical standards, not reader interpretation.

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

Not applicable. This device is a physical medical device (surgical gloves), not an algorithm or software. Its performance is inherent to its physical properties, not a standalone algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these tests are the established, objective criteria defined within the referenced ASTM standards (e.g., ASTM D 3577-01E1, ASTM D 6124-01, ASTM D 5712-95) and FDA regulations (21 CFR 800.20) for the physical, chemical, and biological properties of surgical gloves. These standards specify how each characteristic should be measured and what constitutes an acceptable result.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device, so there is no "training set." The device performance is based on manufacturing specifications and testing against established standards.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

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