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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

Here's a summary of the acceptance criteria and the study details for the Hongze Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue, based on the provided text:

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 test. However, it references:

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
• Pinhole Detection (FDA 1000 ml. Water Fill Test): AQL 2.5, inspection level I.

The data provenance is not explicitly stated as "country of origin" but the submitting company is "Hongze Plastic Technology Co., Ltd. West District of Shenze Industrial Zone, Fuqian West Road, Shenze County, Shijiazhuang, Hebei, China". The studies are presented as non-clinical tests performed by the manufacturer to demonstrate substantial equivalence, implying they were conducted after the device's creation (retrospective to the submission, but likely prospective tests during manufacturing/quality control).

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

This information is not applicable as the device is a patient examination glove and the testing involves objective physical, chemical, and biological performance criteria against established standards, not interpretation by medical experts.

4. Adjudication Method for the Test Set

This is not applicable. The tests are objective measurements against defined standards (e.g., AQL levels for physical properties, specific thresholds for irritancy). There is no "ground truth" established by human interpretation that would require an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging or interpretation devices where human performance with and without AI assistance is evaluated. This is not relevant for a patient examination glove.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. The tests performed are inherent to the product's physical and biological properties.

7. Type of Ground Truth Used

The "ground truth" for the performance tests is based on:

• Established ASTM Standards: D 6319-00a (2005)e1 for physical and dimensional properties, and D 6124-06 for residual powder.
• FDA Requirements: Specifically for the 1000 ml Water Fill Test for pinholes.
• Biocompatibility Testing Protocols: To determine if there are primary skin irritant or sensitization reactions.

8. Sample Size for the Training Set

This is not applicable. The device is not a machine learning model; therefore, there is no "training set."

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

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

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