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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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A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.

Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

The document describes the acceptance criteria and performance data for Innovative Gloves Company Limited's Nitrile Examination Gloves Powder-Free (Black Color).

This is a premarket notification (510(k)) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive de novo clinical trials with independent ground truth establishment or MRMC studies. The "study" here refers to the testing performed against recognized standards.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, number of participants for skin irritation). It only states that the device "Meets" the specified standards. ASTM and ISO standards for medical gloves typically specify sampling plans and test methods, but the raw data or detailed sample sizes are not provided in this summary.
• Data Provenance: The tests were conducted by Innovative Gloves Company Limited, based in Thailand. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance with the relevant standards.

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

• This is not applicable in the context of this device and report. The "ground truth" here is adherence to established international and national standards (ASTM and ISO) for physical properties and biocompatibility. There isn't an "expert consensus" in the way one would establish ground truth for an AI diagnostic algorithm for image interpretation. The standards themselves define the criteria for "ground truth" performance.

4. Adjudication Method for the Test Set

• Not applicable. The tests are laboratory-based and objective measurements against established standard specifications, not subjective assessments requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-assisted diagnostic tool for which MRMC studies are typically performed.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Not applicable. This device is a physical product (a glove), not an algorithm.

7. Type of Ground Truth Used

• The ground truth for this device's performance is established by the specifications and methodologies outlined in the referenced international standards (ASTM D 6319-00a and ISO 10993, Part 10:2002(E)). These standards define acceptable ranges for dimensions, physical properties, pinhole freedom, powder content, and biological reactivity.

8. Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI model that requires a training set. The manufacturing process is controlled, and quality control tests (which are the "performance" data here) are done on samples from production batches.

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

• Not applicable, as there is no training set for a physical medical device like a glove.

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