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A 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 NITRILE EXAM GLOVES, COLOR: BLUE

The provided text describes the 510(k) summary for the NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD. Powder-Free Nitrile Exam Gloves, Color: Blue. This is a Class I medical device, specifically patient examination gloves.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for testing each standard. It only mentions that the device "met or exceeded" the listed standards. For devices like examination gloves, testing typically involves destructive sampling from production batches. The provenance of this data is not specified in terms of country of origin or whether it was retrospective or prospective, though it would generally be prospective testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to the evaluation of examination gloves. The "ground truth" for glove performance is established by the specifications defined in the referenced industry standards (e.g., ASTM, ISO), which involve objective physical, chemical, and biological measurements, not expert consensus on interpretations.

4. Adjudication method for the test set:

Not applicable. The tests are objective measurements against defined pass/fail criteria within the standards, not subjective interpretations requiring adjudication.

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:

Not applicable. This is for a physical medical device (examination gloves), not an AI-powered diagnostic tool engaging human "readers."

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

Not applicable. This is for a physical medical device (examination gloves), not an algorithm.

7. The type of ground truth used:

The ground truth is established by the specifications and testing methodologies outlined in the referenced industry standards (ASTM D 6124-01, ASTM D 6319-00aE3, ASTM D 5151-99, ISO 2859, MIL Std 105E) and specific biocompatibility and bioburden testing procedures (e.g., Procedure Method 8315). These standards define acceptable limits for properties like dimensions, physical integrity (e.g., tensile strength, elongation), barrier protection (e.g., pinholes), and biological safety.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable. This is not an AI/machine learning device. The "ground truth" for manufacturing and quality control of the gloves is based on adherence to the aforementioned industry standards.

Summary of Study (from the provided text):

The study demonstrating the device meets the acceptance criteria is implicitly the testing performed against a series of established national and international standards for patient examination gloves. The submission states, "This device has met or exceeded the following standards and/or tests." This implies that the manufacturer conducted the required tests as per these standards, and the results demonstrated compliance. The specific details of these tests (e.g., number of gloves tested for tensile strength, specific bioburden levels) are not provided in this summary but would be part of the full 510(k) submission.

The conclusion of the summary is that the device is "substantially equivalent to the devices approved as K011286 and K000670," which suggests that its performance against these standards is comparable to previously cleared predicate devices.

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