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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, White (Non-colored)":

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., how many gloves were tested for pinholes, or how many animals for biocompatibility). However, the tests are conducted in accordance with referenced standards (ASTM D 5250-00c4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards typically specify sample sizes or methodologies for such testing.

The data provenance is not specified beyond "Hebei Manful Import & Export Co., Ltd." as the submitter, located in China. The studies are non-clinical (laboratory testing) and are retrospective in the sense that they were completed before the 510(k) submission.

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

This information is not provided. For non-clinical, objective performance tests like those conducted for examination gloves (dimensional, physical properties, pinholes, powder amount), the "ground truth" is typically established by laboratory measurements against defined standards, rather than expert consensus on subjective findings. For biocompatibility, the ground truth is established by the observed biological response in animal models, interpreted by qualified toxicologists or study directors, though their number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical performance and biocompatibility studies. The results are typically objective measurements or observations against predefined pass/fail criteria according to the referenced standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Examination gloves are medical devices with objective performance criteria.

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

Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against the specified standards without human interaction influencing the device's function or interpretation of its output. The device itself (the glove) is not an algorithm, so "algorithm only" is not directly applicable. However, its physical characteristics and biological safety were tested in an isolated manner.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Defined Standards: For dimensions, physical properties, powder amount, and freedom from pinholes, the "ground truth" is adherence to the specified ASTM and CFR standards with their quantitative limits.
• Laboratory Observations/Measurements: For biocompatibility, the ground truth is established through observed biological responses in animal models (e.g., presence or absence of irritation or sensitization), as interpreted by testing personnel/toxicologists following the ISO standard.

8. Sample Size for the Training Set

Not applicable. This device is an examination glove, not an AI/ML algorithm or a device that requires a "training set" in the context of machine learning. The studies described are performance and safety tests, not algorithm training.

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

Not applicable, as there is no training set for this device.

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