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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and related study information for the device described in the provided 510(k) summary:

This device is a Powder free Vinyl Patient Examination Glove. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which primarily involves meeting recognized standards for physical properties, safety, and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized ASTM standards and FDA regulations for patient examination gloves. The reported device performance states that the device "Meets" these standards.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for testing each characteristic (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It simply states that the device "Meets" the standards.
• Data Provenance: The tests are implied to be conducted by the manufacturer, TANGSHAN KANGJIA GLOVE CO., LTD., which is based in China. The data could be considered internal manufacturer data from China. Whether it's retrospective or prospective is not explicitly stated, but typically these types of tests are conducted prospectively as part of product development and quality control.

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

This type of device (patient examination glove) does not typically involve "experts" establishing a "ground truth" in the way a diagnostic imaging AI algorithm would. The "ground truth" here is defined by objective, measurable criteria specified in ASTM standards and FDA regulations (e.g., a pinhole is present or not, tensile strength is within a range). Therefore, no "experts" in the clinical sense are used to establish ground truth for this device's performance. The "experts" might be the technicians and engineers who perform the standardized tests.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are not applicable to the testing of patient examination gloves. The tests involve objective measurements and pass/fail criteria based on established standards, rather than subjective interpretations that would require multiple reviewers and adjudication.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically relevant for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases, and the AI's impact on their performance is evaluated. For a patient examination glove, there is no "reading" involved, and therefore, such a study is not applicable.

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

Yes, in a conceptual sense, a "standalone" assessment was done. The device's performance characteristics (dimension, physical properties, freedom from pinholes, powder residual, biocompatibility) were evaluated directly against the established standards without human intervention in the interpretation of the results beyond performing the standardized test. There is no algorithm, but its physical qualities were tested independently.

7. The Type of Ground Truth Used

The ground truth used is primarily objective, measurable criteria defined by recognized standards (ASTM) and regulatory requirements (21 CFR). For example:

• Dimensions: Measured against specified ranges in ASTM D 5250-06.
• Physical Properties: Measured against specified tensile strength, elongation, and other properties in ASTM D 5250-06.
• Freedom from Pinhole: Assessed via water leak test against AQL (Acceptable Quality Level) in 21 CFR 800.20.
• Powder Residual: Measured gravimetrically against the threshold of <2mg/glove.
• Biocompatibility: Assessed through standardized animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) to determine if irritation or sensitization occurs, according to ISO10993-10 guidelines.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. It is a physical product, and its manufacturing and quality control do not typically involve data-driven model training.

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

As there is no training set for this device in the AI/ML sense, the question of how its ground truth was established is not applicable.

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