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Powder free 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.

powder free 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 conducted for "Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)".

Here's the breakdown of the requested information:

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 sample sizes used for each specific test (e.g., dimension, pinholes, physical properties, powder residual, biocompatibility). However, it implies that the tests were conducted according to the respective ASTM standards, 21 CFR 800.20, and ISO10993-10, which would inherently specify sample sizes and methodologies.

The data provenance is from China, as the submitter is SHIJIAZHUANG CENTURY PLASTIC CO., LTD with an address in China. The study appears to be prospective in nature, as new testing was conducted specifically for this 510(k) submission to demonstrate compliance with the referenced standards.

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

This information is not applicable to this type of device and study. The "ground truth" for medical gloves is established by objective measurements against recognized industry standards (ASTM, FDA regulations, ISO) rather than expert consensus on diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. The tests performed on the gloves (e.g., physical properties, pinholes, powder residual, biocompatibility) involve objective measurements and established laboratory procedures, not subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a physical medical glove.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

N/A (Not Applicable). This question pertains to AI/algorithm performance. The device is a physical medical glove, and no algorithm or AI component is involved.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and laboratory test results that demonstrate compliance with established, recognized industry standards and regulations. These include:

• ASTM standard D 5250-06 (for dimensions, physical properties, powder residual)
• ASTM standard D 6124-01 (for powder residual)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility - primary skin irritation and dermal sensitization)

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a physical device like a glove.

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