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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.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, LYZ, and meets all requirements of ASTM D5250-06.

This document is a 510(k) Pre-market Notification for Zibo Huiying Medical Products, Co. Ltd.'s "Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue". It aims to demonstrate substantial equivalence to a predicate device. The information provided heavily relies on non-clinical testing and comparison to established ASTM standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, 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:

• Pinhole Results (ASTM D5151-06): 125 pieces of gloves were tested.
• Physical and Dimensions Testing (ASTM D-5250): Conducted at inspection level S-2, AOL 2.5. The exact sample size is not explicitly stated as number of gloves, but is implied by the AQL (Acceptance Quality Limit) which defines the maximum percentage of defective units in a batch that can be considered satisfactory.
• Residual Powder Test (ASTM D-6124): "start to finish inspection" and "no defect glove found according to ASTM D6124-06." The exact sample size as a number of gloves is not explicitly stated.
• Biocompatibility (ISO 10993-10): Sample sizes for "Primary Skin Irritation" and "Skin Sensitization" tests are not specified in the document, but these typically involve animal testing following established protocols.
• Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the product was tested). The tests were performed by or for Zibo Huiying Medical Products, Co. Ltd., which is located in China. The data would be considered prospective, as it was generated specifically for this 510(k) submission.

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

• Not applicable for this type of device. The assessment of patient examination gloves relies primarily on objective, quantifiable physical and chemical properties and performance tests against established standards (ASTM, ISO). There is no "ground truth" established by human experts in the way clinical images or diagnostic outcomes would be. The ground truth is defined by the scientific and engineering standards themselves.

4. Adjudication Method for the Test Set:

• Not applicable. As there are no human expert readers or subjective assessments requiring adjudication, no adjudication method was used. The tests are objective and quantitative, comparing results directly against specified numerical criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for diagnostic devices where human readers interpret results, often to compare human performance with and without AI assistance. This device (patient examination gloves) is not a diagnostic device and does not involve human interpretation or AI assistance in its primary function.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This device is a medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance is the inherent physical and chemical properties of the glove itself.

7. The Type of Ground Truth Used:

• The ground truth for this device is based on established industry standards and regulatory requirements. Specifically:
  • ASTM standards: ASTM D5250, ASTM D6319-00al (for physical properties), ASTM D6124-06 (for residual powder), ASTM D5151-06 (for pinhole detection).
  • ISO standards: ISO 10993-10 (for biocompatibility).
  • Regulatory requirements: 21 CFR 880.6250 for patient examination gloves.
  • The predicate device's performance also serves as a benchmark for comparison.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set." The manufacturing process itself (which includes quality control and testing) ensures consistency, but there isn't a separate "training" of the product in the way an algorithm is trained on data.

9. How the Ground Truth for the Training Set was established:

• Not applicable. As there is no training set for a physical product like examination gloves, there's no ground truth to be established for it.

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