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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 an analysis of the acceptance criteria and study information for the K102570 submission, formatted as requested:

Acceptance Criteria and Device Performance Study for K102570

The device in question is "Powder free Vinyl Patient Examination Gloves, Colored (Yellow)." The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and FDA regulations for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

Based on the provided document, the studies conducted are non-clinical, focusing on laboratory testing rather than clinical trials involving human subjects.

2. Sample Size for Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, pinholes, etc.). However, it indicates adherence to established standards (ASTM, ISO, 21 CFR), which typically define appropriate sampling methodologies for such tests.

The data provenance is from Tangshan Kangjie Glove Co., Ltd. (China), and the tests would be considered prospective as they were conducted to demonstrate compliance of the manufactured gloves.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable. The "ground truth" for glove performance is established by technical standards and regulations (ASTM D5250-06, 21 CFR 800.20, ASTM D6124-01, ISO10993-10), not by expert consensus on individual cases. Lab technicians and engineers with expertise in these standards would conduct the tests.

4. Adjudication Method for the Test Set

This section is not applicable. The evaluations are based on objective measurements and pass/fail criteria defined by the cited standards, not on subjective interpretations requiring adjudication.

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

An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, sometimes with AI assistance. For patient examination gloves, the performance evaluation is based on material properties and regulatory compliance, not reader interpretation.

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

This section is not applicable. The device is a physical product (gloves), not an algorithm or AI system. Its performance is inherent in its material and manufacturing, not in an independent computational process.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is based on technical standards and regulatory requirements. Specifically:

• ASTM D5250-06: Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This standard dictates requirements for dimensions, physical properties, and powder residue.
• 21 CFR 800.20: Regulations regarding general requirements for performance standards, specifically related to the waterleak test for freedom from pinholes.
• ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of evaluating physical properties of patient examination gloves. The manufacturing process is controlled to ensure consistent product quality, but there isn't a machine learning model being trained.

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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