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The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

This document is a 510(k) summary for Hebei Grandeast Plastic Products Co., Ltd.'s Powder-free PVC Vinyl Exam Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance

Study to Prove Device Meets Acceptance Criteria:

A non-clinical test study was conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device. The test results demonstrated compliance with the following standards:

• ASTM D5250-06 (Reapproved 2011): Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application. This standard covers general requirements for dimensions, physical properties (tensile strength, elongation), and freedom from holes.
• ASTM D5151-06 (Reapproved 2011): Standard Test Method For Detection Of Holes In Medical Gloves. This standard specifies the method for testing for holes.
• ASTM D6124-06 (Reaffirmation 2011): Standard Test Method For Residual Powder On Medical Gloves. This standard specifies the method for testing the amount of residual powder.
• ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. This standard governs biocompatibility testing.

The document indicates that the proposed device complies with all these standards and their specific requirements, thereby demonstrating that it meets the acceptance criteria.

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

The document does not explicitly state the specific sample sizes used for each test. It broadly states "Non clinical tests were conducted to verify that the proposed device met all design specifications..." The data provenance is implied to be from Hebei Grandeast Plastic Products Co., Ltd. in Julu County, Hebei Province, China, where the device manufacturer is located. The nature of these tests (e.g., laboratory testing of physical and chemical properties) would inherently be prospective for the specific batches tested to support the 510(k) submission.

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)

This section is not applicable to this type of device (patient examination gloves). The "ground truth" for medical gloves is established by objective, standardized laboratory tests against recognized ASTM and ISO standards, not by expert human interpretation or consensus.

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

This section is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, often in imaging or clinical trials. The tests for medical gloves are objective and rely on standardized measurement techniques.

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

This section is not applicable. MRMC studies are used to evaluate the performance of diagnostic devices often involving human readers and interpretations, especially in conjunction with AI. This document pertains to non-clinical testing of patient examination gloves.

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

This section is not applicable. This device is a physical medical glove, not a software algorithm or AI system.

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

The "ground truth" for this device is based on objective measurements and criteria defined in recognized international standards (ASTM and ISO) for physical properties (dimensions, tensile strength, elongation), functional performance (freedom from holes, residual powder), and biocompatibility (irritation, sensitization). These standards provide the accepted benchmarks for safety and effectiveness for patient examination gloves.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the same reason as point 8.

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