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

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578

This is a 510(k) premarket notification for a medical device (Powder Free Latex Patient Examination Gloves), not an AI/ML medical device. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted relevant to the provided text:

Acceptance Criteria and Device Performance

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for testing each characteristic. The "data provenance" is not explicitly stated in terms of country of origin for the test data, but the submitter is based in Malaysia. The testing would be prospective in nature, as it relates to testing the manufactured product before marketing.

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 physical product, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" is defined by the objective measurement adhering to industry standards (ASTM, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Testing involves objective measurements against established physical and chemical standards, not subjective expert 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 for a physical medical glove, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a physical medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is established by the international and national standards referenced (ASTM D 3578-10, ASTM D 5151-11, ASTM D 6124-11, ASTM D 5712-10, ISO 10993-10:2010). The device is deemed to meet these objective, pre-defined standards.

8. The sample size for the training set:
Not applicable. This is a physical product, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a physical product, not an AI/ML algorithm.

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

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Patient Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document (K123760) does not specify the sample size used for the test set for any of the performance characteristics. It only states that the device "Meets" the standards or passes the biocompatibility tests.

The data provenance is not explicitly stated as "country of origin" for the specific test data, but the submitter is based in Malaysia. The testing refers to international and US-based standards (ASTM, ISO, CFR), implying these tests were conducted according to those guidelines, potentially by an accredited lab. The study is retrospective in the sense that the test data was collected prior to this submission, but it's not a clinical study involving patients over time.

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

This information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards, not through clinical expert review or diagnosis of medical images/conditions. The "ground truth" for this type of device is defined by the technical specifications outlined in the ASTM, ISO, and CFR standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective assessments, often by human readers (e.g., radiologists interpreting images). The performance of these gloves is assessed objectively against quantifiable standards.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. This document describes a physical medical device (gloves) and its conformity to technical standards.

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

This information is not applicable. This device is a physical product, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on established industry standards and regulatory criteria. These involve:

• Physical Specifications: ASTM D6319-10 for dimensions and physical properties.
• Freedom from Defects: ASTM D5151-11 and D6319-10 for pin-holes.
• Chemical Properties: ASTM D6124-11 and D6319-10 for powder-free residue.
• Biocompatibility: ISO 10993-10:2010 for dermal sensitization and 16 CFR Part 1500 for primary skin irritation.

These standards define the acceptable range or limits for each characteristic.

8. The Sample Size for the Training Set

This information is not applicable. This submission concerns a physical medical device and its conformity to standards. There is no AI or machine learning "training set" involved in its evaluation.

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

This information is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation, as described in point 7, is established by industry and regulatory bodies through the development and publication of the relevant standards.

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