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

The subject device is powder free vinyl examination gloves, adding 1%-3% nitrile to improve the tensile strength and ultimate elongation. The subject device is blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Synthetic Nitrile Examination Gloves. It details the device's characteristics, its intended use, and comparative testing against a predicate device to establish substantial equivalence.

Based on the document, I can provide the acceptance criteria and study details for the device as follows:

Acceptance Criteria and Device Performance

The acceptance criteria for the Synthetic Nitrile Examination Gloves are primarily based on performance standards and biocompatibility. The reported device performance is compared against these criteria.

Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The document focuses on non-clinical testing for the device's physical properties and biocompatibility.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document explicitly mentions a sample size of 125 for the "Watertightness Test for Detection of Holes" (0/125). For other tests (Dimensions, Powder Content, Physical Properties, Biocompatibility), specific sample sizes are not detailed in the provided tables, but general industry standards for these tests typically involve a statistically significant number of samples from production lots.
   • Data Provenance: The manufacturing site is Shandong Hongxin Chemicals Co.,Ltd. in Zibo City, Shandong Province, China. The official correspondent is Shanghai Truthful Information Technology Co., Ltd. also in China. Therefore, the data provenance is from China, and the studies are retrospective as they were conducted to obtain premarket clearance for existing device designs.

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

   • This section is not applicable to this type of device and study. The testing for examination gloves involves objective physical and chemical measurements (e.g., tensile strength, dimensions, freedom from holes, biocompatibility tests). These are not expert-derived "ground truth" in the way an AI diagnostic algorithm for medical images would require radiologists for ground truth labeling. The "ground truth" is defined by the established and published ASTM and ISO standards themselves.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are typically used in studies involving subjective expert interpretation, such as medical image reading or clinical diagnoses where there might be inter-reader variability. For the physical and chemical testing of medical gloves, the results are objective measurements against defined standards, not subject to expert adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

   • No. An MRMC study is relevant for AI-assisted diagnostic devices that involve human readers. This device is a physical medical product (examination gloves), not an AI algorithm for diagnosis, so an MRMC study was not performed and is not applicable.

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

   • No. This is a physical medical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance testing is based on established international consensus standards (ASTM and ISO). These standards define the physical, mechanical, and biological properties a patient examination glove must meet for its intended use. For example:
     • Physical/Mechanical Properties: ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412.
     • Biocompatibility: ISO 10993-10, ISO 10993-11.
   • The ground truth is not derived from expert consensus on individual cases, pathology, or outcomes data in the way it would be for a diagnostic tool.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical medical device, not a machine learning model or AI algorithm that requires a "training set." The device is manufactured and then tested against established performance standards.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" for physical examination gloves. The manufacturing process is controlled via quality systems (e.g., 21 CFR Part 820 for QMSR) and tested to ensure conformity to the established standards as outlined in point 6.

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