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A powder-free 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.

Powder-free Black Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.

The provided text describes the performance testing and acceptance criteria for "Black Nitrile Examination Gloves, Powder Free, Non Sterile." Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document also mentions other performance testing standards such as Water Leak Test (G-I, AQL 1.5), Visual Inspection (Critical AQL 0.65, Major AQL 2.5, Minor AQL 4.0), Residual Powder (N=5), and Moisture Content (N=8) in Section 5.0. However, the specific performance values for these tests are not detailed in Section 7.0 for the device.

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

The document mentions sample sizes for some tests:

• Residual Powder: N = 5
• Moisture Content: N = 8

For other tests like water leak, physical dimension, physical properties, and visual inspection, AQL (Acceptable Quality Limit) levels (e.g., G-I, AQL 1.5; S-2, AQL 4.0; S-2, AQL 2.5) are specified. These AQLs are part of a sampling plan that determines the sample size and acceptance/rejection criteria based on the lot size, but the exact number of units tested for each batch is not explicitly stated as a single "sample size" in the provided text.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. The submitter is PT MAHAKARYA INTI BUANA, located in SUMUT – INDONESIA, implying the tests were conducted by or for them.

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

Not applicable. This is a medical device (gloves) and the "ground truth" for its performance is established by objective measurements against established engineering and safety standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20), not by expert human consensus on image interpretation or similar.

4. Adjudication Method for the Test Set:

Not applicable. See point 3. Testing involves objective measurements, not human interpretation that requires 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 is not an AI-powered diagnostic device.

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

Not applicable. This is a physical medical device (gloves), not an algorithm.

7. The type of ground truth used:

• Objective Measurements/Standards: The ground truth for performance claims is based on established international and national standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20) for physical properties, dimensions, freedom from pinholes, moisture content, and powder residue.
• Biological Testing: Biocompatibility (Primary Skin Irritation and Dermal Sensitization) uses standardized laboratory animal tests (rabbits) to determine "Pass" or "Fail" based on observed biological responses.

8. The Sample Size for the Training Set:

Not applicable. This product does not involve machine learning or AI, so there is no "training set."

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

Not applicable. See point 8.

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