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The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

Here's an analysis of the provided 510(k) submission, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove (Non-Sterile)

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 sample sizes used for the non-clinical performance tests (ASTM standards) or the biocompatibility tests (ISO standards). The results are reported as "Conforms," "Passes," or "Not tested," implying that the testing was conducted according to the methodology outlined in the respective standards.

For biocompatibility, the tests were conducted, but the specific number of animals or human subjects (if applicable for irritation/sensitization under specific protocols) is not provided.

The data provenance is from testing conducted by the manufacturer, Best Glove, Inc. No country of origin for the data is specified beyond the company's location in the USA. The tests are prospective as they were conducted to demonstrate the safety and effectiveness of the new device for the 510(k) submission.

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

This submission does not involve an expert-reviewed test set in the way a medical image analysis or diagnostic device might. The "ground truth" for this device (medical examination glove) is established by its adherence to established performance standards (ASTM) and biocompatibility standards (ISO).

Therefore, there were no "experts" in the traditional sense involved in establishing a ground truth for a test set for diagnostic accuracy. Instead, the "ground truth" is defined by the passing criteria of the specified international standards for glove performance and safety. The expertise lies in the certified laboratories and personnel who conduct these standardized tests according to the established protocols.

4. Adjudication Method for the Test Set

Not applicable. This device is not a diagnostic tool requiring expert adjudication of results. The performance and biocompatibility tests are based on objective measurements and established pass/fail criteria within the relevant ASTM and ISO standards.

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 devices where human readers interpret data (e.g., medical images) and AI might assist in that interpretation. This submission is for a medical examination glove, which does not involve human readers interpreting diagnostic information.

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 and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used is based on established objective performance criteria and biocompatibility thresholds defined by recognized international standards:

• Performance: ASTM D 6319-00a/06, ASTM D 6124-01/06, ASTM D 5151-99/06. These standards define physical properties like tensile strength, elongation, puncture resistance, and watertightness, with specific acceptance limits.
• Biocompatibility: ISO 10993-10 (for irritation and sensitization) and ISO 10993-5 (for cytotoxicity). These standards define acceptable biological responses when the device comes into contact with tissues.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove and does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process and quality control are based on established engineering principles and quality management systems, not data training.

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

Not applicable, as there is no training set for this type of device.

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