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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.

Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance of "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Blue)" and "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Green)" as detailed in the K993133 510(k) submission.

Here's the 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 specific sample sizes used for each individual test (e.g., how many gloves were tested for watertightness, length, etc.). However, it refers to compliance with ASTM D3578-95 and FDA 1000 ml watertight test, which implicitly defines the sampling plans and methodologies.

The data provenance is not explicitly mentioned as a country of origin for the data itself, but the manufacturer, SEAL POLYMER INDUSTRIES SDN. BHD., is located in Malaysia. The study is a retrospective evaluation of the product's performance against established standards, not a prospective clinical trial.

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

This information is not provided in the document. The "ground truth" for the performance criteria is established by the specified industry standards (ASTM D3578-95 and FDA guidelines) rather than expert consensus on individual cases. These standards define the measurable thresholds for passing or failing each test.

4. Adjudication Method for the Test Set:

This information is not applicable in the context of these device performance tests. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations where human consensus on an interpretation of a medical image or condition is required. For the physical and chemical properties of gloves, the results are objective measurements against defined criteria.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is irrelevant for the evaluation of examination gloves, which are physical devices with measurable performance characteristics, not diagnostic AI systems assisting human readers.

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

No. This question is also irrelevant as the device is a physical examination glove, not an algorithm. The "performance" described is the physical and chemical properties of the glove itself, not an algorithm's output.

7. The Type of Ground Truth Used:

The ground truth used is primarily industry standards and regulatory requirements. Specifically:

• ASTM D3578-95 Standard: This standard defines the physical requirements and test methods for rubber examination gloves.
• FDA 1000 ml watertight test: A specific regulatory requirement for glove integrity.
• FDA minimum powder content: A specific regulatory requirement for powder levels in gloves.
• Biocompatibility tests: These tests (Primary Dermal Irritation Test and Guinea Pig Sensitization) adhere to established protocols to determine a material's biological compatibility.

8. The Sample Size for the Training Set:

This information is not applicable as there is no "training set" in the context of evaluating the physical properties of a medical device like examination gloves. Training sets are used for machine learning models.

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

This information is not applicable as there is no training set involved.

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