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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

This document is a 510(k) Summary for Synthetic Vinyl Examination Gloves, a Class I medical device. It details the device's characteristics and its equivalence to a predicate device, supported by non-clinical testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Dimensions (ASTM D5250): The sample sizes are implied by the ranges provided for width and thickness (e.g., "XS: 78-79/ Pass" suggests testing across multiple samples within each size). No explicit total sample size or country of origin for the data is provided, but the manufacturer is based in China. The testing is non-clinical.
• Watertightness Test for Detection of Holes (ASTM D5151): 125 leaks were tested from a sample size that is not explicitly stated. The method is "0/125 leaks / Pass", suggesting 125 units were tested (or 125 opportunities for leaks in a larger sample).
• Powder Content (ASTM D6124): "Medium glove is the representative sample of the product." The exact number of medium gloves tested is not specified.
• Physical Properties (ASTM D412): "Medium glove is the representative sample of the product." The exact number of medium gloves tested is not specified.
• Biocompatibility (ISO 10993-5, ISO 10993-10): The studies were conducted on the subject device. No explicit sample size for these biological tests is provided, nor the country of origin of the data.

All data provenance is implied to be from non-clinical laboratory testing performed by or for Yunnan Huazhiyuan Medical Technology Co., Ltd. in China, as indicated by the submitter's information. All studies are retrospective in the sense that they are evaluations of a fully developed product.

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

This document describes non-clinical performance and biocompatibility testing for a medical glove. No human-derived ground truth or expert consensus was used to establish the "ground truth" for the test set. The acceptance criteria are based on established international standards (ASTM and ISO).

4. Adjudication Method for the Test Set

There was no adjudication method as this involved quantitative laboratory testing against pre-defined scientific standards rather than subjective human assessment requiring consensus.

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

No MRMC comparative effectiveness study was done. This is a non-clinical submission for a Class I general hospital device (examination gloves). Such studies are not applicable or required for this type of device.

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

Not Applicable. This device is a physical medical glove, not an algorithm or AI-driven system. The testing is standalone in the sense that the device's performance was evaluated intrinsically against standards, without human intervention affecting its core function during testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on established international standards and specifications:

• ASTM D5250: Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
• ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (implied basis for physical properties).
• ISO 10993-5: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
• ISO 10993-10: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not Applicable. As no training set was used, no ground truth needed to be established for it.

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