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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 5250-0064

This document describes the acceptance criteria and the study conducted to demonstrate that the medical device in question, "FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, White (Non-colored)," meets these criteria.

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. However, it references established industry standards from ASTM and FDA regulations, which typically prescribe statistically significant sample sizes for their respective testing methodologies.

• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The testing was conducted by the manufacturer, Shijiazhuang Fuguan Plastic Products Co., Ltd., which is based in Hebei Province, P.R. China.

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

The document does not mention the use of experts to establish ground truth for the test set. The acceptance criteria are based on established regulatory standards (21 CFR 800.20) and industry standards (ASTM D 5250-00e4, ASTM D6124-01, ISO10993-10). The device's performance was evaluated against these predefined objective criteria rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements against established standards, not on subjective assessments requiring adjudication.

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

No. This type of study is not applicable to the assessment of patient examination gloves. MRMC studies are typically used for diagnostic or screening devices where human interpretation is involved.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (gloves), not an algorithm or software. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is based on established regulatory and industry standards. These standards define the acceptable physical, mechanical, and biocompatibility properties for patient examination gloves.

• ASTM D 5250-00e4: Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This standard dictates requirements for dimensions, physical properties, and powder amount.
• 21 CFR 800.20: This FDA regulation covers "Indirectly Heated Autoclaves," but in this context, it is referenced for "Freedom from pinholes," which is a specific test for barrier integrity.
• ASTM D 6124-01: Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI algorithms that require a "training set." The testing performed is for product quality and compliance with standards.

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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