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Powder free vinyl 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

The document discusses the regulatory submission for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" by TANGSHAN FUQIANG GLOVE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device by meeting established standards for patient examination gloves.

Here's an analysis of the acceptance criteria and related study information 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 (e.g., for pinholes, physical properties, or biocompatibility). However, it implies that the tests were conducted according to the specified ASTM standards and CFR regulations, which would include defined sample size requirements within those standards.

• Provenance: The tests were conducted by the manufacturer, TANGSHAN FUQIANG GLOVE CO., LTD., which is based in Hebei Province, China. The testing itself is presented as non-clinical data, implying a retrospective analysis of manufacturing quality control and standard-driven testing.

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

This information is not provided in the document. The evaluations are based on meeting specified objective standards (ASTM, CFR), not on expert consensus for subjective interpretation.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple human readers. Since this submission relies on objective testing against established engineering and biological standards for a Class I general purpose device (patient examination gloves), an adjudication method is not applicable and therefore not mentioned. The "ground truth" is determined by whether the device's physical and biological characteristics meet the specified thresholds in the standards.

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Patient examination gloves are a Class I device with clear objective performance criteria, not requiring human interpretation of clinical cases.

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

This question is not applicable. The device is a physical product (patient examination glove), not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant. The device's "standalone" performance is its ability to meet the defined physical and biological standards.

7. Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and regulatory requirements:

• ASTM standard D 5250-06: For dimensions and physical properties.
• ASTM standard D 6124-06: For powder residual.
• 21 CFR 800.20: For freedom from pinholes (waterleak test AQL).
• ISO10993-10 (implied basis for biocompatibility tests): For primary skin irritation and dermal sensitization.

8. Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of a physical medical device like a glove. Training sets are typically used for machine learning algorithms. The manufacturer conducts quality control and testing on production batches to ensure consistency with the standards.

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

This question is not applicable for the same reasons as point 8. The "ground truth" for compliance testing is defined by the objective metrics and thresholds within the cited ASTM and CFR standards.

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