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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

Here's a summary of the acceptance criteria and the study details for the Hongze Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue, based on the provided text:

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 test. However, it references:

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
• Pinhole Detection (FDA 1000 ml. Water Fill Test): AQL 2.5, inspection level I.

The data provenance is not explicitly stated as "country of origin" but the submitting company is "Hongze Plastic Technology Co., Ltd. West District of Shenze Industrial Zone, Fuqian West Road, Shenze County, Shijiazhuang, Hebei, China". The studies are presented as non-clinical tests performed by the manufacturer to demonstrate substantial equivalence, implying they were conducted after the device's creation (retrospective to the submission, but likely prospective tests during manufacturing/quality control).

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

This information is not applicable as the device is a patient examination glove and the testing involves objective physical, chemical, and biological performance criteria against established standards, not interpretation by medical experts.

4. Adjudication Method for the Test Set

This is not applicable. The tests are objective measurements against defined standards (e.g., AQL levels for physical properties, specific thresholds for irritancy). There is no "ground truth" established by human interpretation that would require an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging or interpretation devices where human performance with and without AI assistance is evaluated. This is not relevant for a patient examination glove.

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

This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. The tests performed are inherent to the product's physical and biological properties.

7. Type of Ground Truth Used

The "ground truth" for the performance tests is based on:

• Established ASTM Standards: D 6319-00a (2005)e1 for physical and dimensional properties, and D 6124-06 for residual powder.
• FDA Requirements: Specifically for the 1000 ml Water Fill Test for pinholes.
• Biocompatibility Testing Protocols: To determine if there are primary skin irritant or sensitization reactions.

8. Sample Size for the Training Set

This is not applicable. The device is not a machine learning model; therefore, there is no "training set."

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

This is not applicable as there is no training set for this device.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

The provided text describes the regulatory clearance for "Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue." It outlines the device's characteristics, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. A 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)

• Pinhole (Water Fill Test): Inspection level I, AQL 2.5. The specific number of samples is not explicitly stated but is implied by the AQL (Acceptable Quality Limit) and inspection level. These are statistical sampling plans.
• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. Similar to the pinhole test, the exact number isn't given but is derived from the AQL and inspection level.
• Primary Skin Irritation and Skin Sensitization: The sample size for these biological tests is not specified in the document.
• Residual Powder Test: Not explicitly stated but implies testing of "finished inspection" gloves.
• Data Provenance: The manufacturing company, Better Care Plastic Technology Co., Ltd., is located in Hebei Province, China. It is highly likely the testing was conducted in China. The data is presented as results from tests performed on the device during its production or evaluation, implying a prospective testing approach for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this device. This document describes the testing of a physical medical device (examination gloves) for performance characteristics (e.g., strength, impermeability, biocompatibility) against established engineering standards (ASTM) and regulatory requirements (FDA). It does not involve human interpretation of data where "ground truth" would be established by experts.

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

This is not applicable as the evaluation involves objective physical and chemical measurements against predefined standards, not subjective expert assessment requiring 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

This is not applicable. The device is an examination glove, not an AI-assisted diagnostic or interpretative system.

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

This is not applicable. The device is an examination glove, not an algorithm or AI system.

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

The "ground truth" in this context is defined by established regulatory and industry standards:

• ASTM D 6319-00a (2005)e1 for physical and dimensional properties.
• FDA 1000 ml. Water Fill Test for pinhole integrity.
• ASTM D 6124-06 for residual powder.
• Biocompatibility testing against generally accepted methods for primary skin irritation and sensitization.

8. The sample size for the training set

This is not applicable. There is no "training set" as this device is a physical product, not a machine learning model.

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

This is not applicable for the same reasons as point 8.

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