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Powder-Free Yellow Vinyl Patient Examination Gloves is a non-sterile 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

This document is a 510(k) summary for the Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than a traditional study proving a device meets specific acceptance criteria for a new clinical claim. Therefore, the information provided will be structured to align with the content of this regulatory submission.

1. Acceptance Criteria and Reported Device Performance (Summary of Equivalence to Predicate)

The device demonstrates substantial equivalence by meeting the same ASTM standards and regulatory requirements as the predicate device.

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

The document does not specify a separate "test set" in the context of a typical clinical study. The performance characteristics for the Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves were evaluated against established ASTM standards (D5250, D5151, D6124) and FDA regulations (21 CFR 800.20).

• Sample sizes for testing: The specific sample sizes used for each test (e.g., tensile strength, pinholes, residual powder) are not explicitly stated in this summary. These would typically be defined within the referenced ASTM standards.
• Data Provenance: The device is manufactured by Ideal Plastic Co., Ltd. in China. The testing would have been conducted by or for the manufacturer, likely in China or by certified laboratories. The data itself is "nonclinical" and laboratory-based, not patient data.

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

Not applicable in the context of this 510(k) submission. This type of submission relies on conformity to established engineering and material standards, and bench testing, rather than expert-derived ground truth from complex medical images or clinical scenarios. The "ground truth" here is the adherence to the specifications outlined in the ASTM standards and FDA regulations, verified through standardized testing methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a conformity assessment based on standardized tests, not an expert-driven adjudication process.

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

Not applicable. This device is a Class I patient examination glove, and its substantial equivalence is demonstrated through physical and chemical property testing, not through MRMC studies comparing human reader performance. Its function is as a barrier, not an interpretative tool.

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

Not applicable. This is a physical medical device (glove), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" is defined by the established performance specifications within the referenced ASTM standards (D5250-06, D5151-06, D6124-06) and FDA regulations (21 CFR 800.20), along with the biocompatibility requirements of ISO 10993-10. The device's performance is compared directly to these objective, quantitative standards.

8. Sample Size for the Training Set

Not applicable. This is a physical device, and the concept of a "training set" for an algorithm does not apply. The manufacturing process is controlled to ensure consistent product attributes, not to "train" a model.

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

Not applicable, for the same reasons as point 8.

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