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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

The Powder Free Nitrile (Black) Examination Gloves meets all the requirements of ASTM Specification D6319-10 -Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance of "Powder Free Nitrile (Black) Examination Gloves" by Gallant Quality SDN. BHD. It is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the requested information based on the document:

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 specify the exact sample sizes used for each test. It states that the device performance "meets ASTM D6319-10 Standard requirements" or similar phrases, implying that testing was conducted according to those standards, which would typically define sample sizes.

The data provenance is from Malaysia, as the submitter (Gallant Quality SDN. BHD.) is located in Taiping, Perak, Malaysia. The study appears to be retrospective, as it presents the results of tests already conducted, demonstrating compliance with established standards for the purpose of a 510(k) submission.

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 in the document. For medical gloves, ground truth is typically established through direct physical and chemical testing against a consensus standard (like ASTM or ISO), rather than human expert opinion on images or clinical cases. The "experts" would be the laboratory personnel performing the standardized tests, and their qualifications would be adherence to the test methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the evaluations are based on objective physical, chemical, and biological tests according to established standards (ASTM, ISO, CFR), not subjective assessments requiring adjudication by multiple readers.

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, a multi-reader multi-case comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for medical examination gloves.

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

No, a standalone algorithm-only performance study was not done. This device is a physical medical glove and does not involve any algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is based on consensus standards and regulatory requirements, specifically:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
• ISO 10993-10:2010: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
• 21 CFR 800.20: Regulations regarding general requirements for examination gloves.
• ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.

These standards define the acceptable physical properties, biocompatibility, and integrity for medical examination gloves.

8. The sample size for the training set

Not applicable. This device is a physical product (medical glove) and does not involve machine learning models that require training sets.

9. How the ground truth for the training set was established

Not applicable. As stated in point 8, there is no training set for this type of device.

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A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or finger(s) to prevent contamination between patient and examiner.

POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES

This document is a 510(k) clearance letter from the FDA for Powder-Free Nitrile (Black) Examination Gloves. It does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device or AI system.

The text explains that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include any performance data or study details typically found in a summary of safety and effectiveness.

Therefore, I cannot fulfill your request for the specific information.

Ask a specific question about this device