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Powdered 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-004

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies for the device:

Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)
510(k) Number: K062520

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 sample sizes used for the tests to demonstrate compliance with the ASTM standards or 21 CFR 800.20. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.

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

This section is not applicable. The device is a medical glove, where "ground truth" typically refers to objective measurements and adherence to engineering standards rather than expert consensus on medical images or diagnoses. The "ground truth" here is the pass/fail result against established material properties and biocompatibility tests.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image analysis for disease detection. For device testing against objective standards, the results are typically binary (pass/fail) based on direct measurement.

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

No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on reader performance is evaluated. For a medical glove, this is not applicable.

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

This section is not applicable. The device is a physical product (a medical glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The performance evaluation focuses on the inherent physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on objective measurements against established national and international standards and regulations. Specifically:

• Physical and Dimension Properties: ASTM standard D 5250-00e4
• Freedom from Pinholes: 21 CFR 800.20
• Powder Amount: ASTM standard D 5250-00e4
• Biocompatibility: Primary Skin Irritation in rabbits (ISO10993-10) and Dermal sensitization in the guinea pig (ISO10993-10).

8. Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm or a diagnostic tool that requires a training set. The manufacturing process of gloves relies on established engineering and materials science principles, not machine learning.

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

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

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