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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

This submission is for a medical glove, which is a relatively simple device. The "acceptance criteria" and "study" framework usually applies to more complex diagnostic or therapeutic devices, especially those using AI. For a glove, the "acceptance criteria" are essentially the performance standards it needs to meet, and the "study" is the testing performed to show it meets those standards.

Here's the information extracted and adapted to your requested format, focusing on the device's characteristics and the standards it aims to meet:

Acceptance Criteria and Study for Powder Free Vinyl Patient Examination Gloves

This device, a Powder Free Vinyl Patient Examination Glove, Clear (non-colored), is designed to meet performance specifications outlined in ASTM standards and other regulations. Its "acceptance criteria" are these specific physical and performance properties, and the "study" demonstrating it meets these is the non-clinical testing against these established standards.

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 individual test (e.g., how many gloves were tested for pinholes, or tensile strength). However, it implies adherence to the sampling plans and methodologies prescribed within the referenced ASTM and ISO standards for vinyl patient examination gloves.

• Data Provenance: The data provenance is from non-clinical bench testing performed by the manufacturer, Zhaofeng Glove Co., Ltd., to demonstrate compliance with international standards (ASTM, ISO, CFR). The country of origin for the manufacturing and testing is China. The data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this 510(k) submission.

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

This section is not applicable as this is a non-AI/software medical device. The "ground truth" for glove performance is defined by the objective, measurable parameters set by the cited ASTM and ISO standards, not by human expert opinion or interpretation of complex data. The tests are purely empirical.

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for human review processes (e.g., radiologist reads) to establish a consensus ground truth, which is not relevant here. The acceptance is determined by meeting objective numerical thresholds in physical tests.

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 relevant for diagnostic or image-interpretation AI devices to compare human performance with and without AI assistance. This device is a physical barrier product, not a diagnostic tool requiring interpretation.

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

No, a standalone performance evaluation was not done. This concept applies to AI algorithms. The device itself is a standalone physical product, and its performance is evaluated through direct physical and chemical testing.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective, measurable physical and chemical properties and performance parameters defined by:

• ASTM D5250-06 (Reaffirmation 2011) - Standard Specification for Vinyl Patient Examination Gloves
• ASTM D5151-06 (Reapproved 2011) - Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
• 21 CFR 800.20 - General provisions for medical devices (specifically regarding barrier integrity)
• ISO 10993-10:2002/Amd.1:2006 or ISO 10993-10 Third Edition 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI or machine learning device. The glove is manufactured to a specified design and material, and its performance is verified through testing of manufactured lots against established standards, not through training an algorithm.

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

This is not applicable as there is no training set for this type of device.

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