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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document describes the acceptance criteria and the study results for the Hebei Tengda Plastic Co., Ltd. Powdered Vinyl Patient Examination Gloves, Clear (Non-colored).

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the specific sample sizes used for each of the tests (Dimension, Physical Properties, Freedom from pinholes, Powder Amount, Biocompatibility). However, it indicates compliance with recognized standards (ASTM D 5250-06, 21 CFR 800.20, ISO10993-10), which inherently define the testing methodologies and sample sizes required for compliance.

The data provenance is from nonclinical studies conducted to demonstrate substantial equivalence. The document does not specify the country of origin where these tests were performed, but it is submitted by a Chinese manufacturer (Hebei Tengda Plastic Co., Ltd.) to the US FDA. The studies would be considered retrospective in the context of this 510(k) submission, as they were conducted prior to the submission to demonstrate compliance.

3. Number of Experts and Qualifications for Ground Truth for Test Set

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing ground truth in the way medical imaging or diagnostic AI devices do. The "ground truth" for the performance criteria is established by the well-defined and objective metrics within the ASTM and FDA standards. Therefore, information about the number of experts or their qualifications for establishing ground truth is not applicable in this context.

4. Adjudication Method for Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical image reading) to resolve disagreements among experts. Since the tests for glove performance are objective and based on measurable physical and chemical properties, an adjudication method is not applicable. The results are directly compared against the quantitative thresholds defined by the standards.

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

No MRMC study was conducted or is applicable for this device. This device is a physical medical device (gloves), not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical product, not an algorithm.

7. Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory requirements, specifically:

• ASTM standard D 5250-06 (for Dimension, Physical Properties, Powder Amount)
• 21 CFR 800.20 (for Freedom from pinholes)
• ISO10993-10 (for Biocompatibility testing, although not explicitly listed in the performance table, it's mentioned as a standard met)

These standards define objective and measurable criteria that the device must meet.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for a physical device.

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