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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.

Here's a breakdown of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" based on the provided document:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a premarket notification for a Class I medical device (patient examination gloves). For such devices, extensive clinical studies are generally not required. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, K032908) by meeting established industry standards and regulatory requirements.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). It references adherence to the standards (ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, ISO10993-10), which would define the required sample sizes for each test.
• Data Provenance: The manufacturing company is TANGSHAN CHANGRONG GLOVE CO., LTD. in China. The testing was conducted to ASTM and ISO standards, which are internationally recognized. The document doesn't explicitly state the country of origin of the data itself beyond the manufacturer's location. The studies are retrospective in the sense that they are conducted on finished product batches to ensure compliance with standards, rather than a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts & Qualifications: Not applicable in the context of this device. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ASTM, ISO, and FDA standards themselves (e.g., a hole is present or not, weight is above/below a threshold, a biological response is observed or not). These are physical and chemical tests, not interpretations by medical experts.

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

• Adjudication Method: Not applicable. The tests are objective and based on established measurement methods and criteria within the referenced standards. There is no subjective interpretation or need for expert consensus adjudication for these types of physical, chemical, and biological safety tests.

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

• MRMC Study: No. This type of study is completely irrelevant for patient examination gloves. MRMC studies are typically used for evaluating diagnostic imaging algorithms where human readers interpret medical images.

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

• Standalone Performance: Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

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

• Type of Ground Truth: The ground truth is based on objective measurements against established scientific and regulatory standards. For example:
  • Dimension: Measured physical dimensions compared to ASTM D5250-06 specified ranges.
  • Physical Properties: Tensile strength, elongation at break, etc., measured according to ASTM D5250-06.
  • Freedom from pinholes: Water leak test (21 CFR 800.20), where the presence or absence of a water leak constitutes the ground truth.
  • Powder Residual: Gravimetric analysis to determine powder weight, compared to the <2mg/glove threshold.
  • Biocompatibility: Observation of specific biological reactions (irritation, sensitization) in animal models as defined by ISO10993-10 protocols.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical product, not an AI/ML algorithm that requires a "training set." The manufacturing process itself (Good Manufacturing Practices) and quality control over successive production batches ensure consistency, rather than a data training process.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set mentioned or relevant for this device.

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