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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 device, based on the provided text:

Acceptance Criteria and Device Performance Study

The device in question is a "Powder Free Vinyl Patient Examination Glove, Clear (non-colored)." The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established standards for such gloves.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the device meets "ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims." This implies that "Meets" for each characteristic means adherence to the specified standard.

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

The provided document does not specify sample sizes for the test set used for the individual performance characteristic evaluations (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility).

The data provenance is implicit: the manufacturer, TANGSHAN GREEN HEALTHCARE CO., LTD., is located in China, suggesting the testing was likely conducted in China, presumably by the manufacturer or a contracted lab. The document does not explicitly state whether the studies were retrospective or prospective, but given they are performance evaluations against a standard, they are typically prospective tests conducted on manufacturing batches.

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

This section is not applicable to this type of device and study. The "ground truth" for glove performance characteristics like dimensions, physical properties, pinholes, and powder residue is established by objective measurements against a defined standard (ASTM, CFR). Biocompatibility studies also follow standardized protocols with objective endpoints (e.g., observation of irritation, sensitization). There is no "expert consensus" needed in the way it might be for image interpretation in medical imaging where human interpretation is the gold standard.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used when there's subjective interpretation or disagreement among multiple human readers, typically in studies involving diagnosis or classification from images or clinical data. The tests for patient examination gloves are objective, and their results are determined by adherence to a quantitative standard.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the diagnostic performance of a system (often AI-assisted) where human readers interpret cases. Patient examination gloves are physical devices, and their effectiveness is determined by their physical and biological properties, not by human interpretation of cases.

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

This section is not applicable as the device is a physical product (gloves), not an algorithm or a software device. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on objective measurements against established industry and regulatory standards. Specifically:

• ASTM D 5250-06: For dimensions, physical properties, and powder residue.
• 21 CFR 800.20: For freedom from pinholes (water leak test AQL).
• ISO10993-10: For biocompatibility (primary skin irritation and dermal sensitization).

These standards define the acceptable range or threshold for each characteristic.

8. Sample Size for the Training Set

Not applicable. The device is a physical product, not an AI/ML algorithm that requires a "training set." The listed studies are performance evaluations against standards, not model development.

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

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

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