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The N-DEX® BWC™ Pink 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)

This device has been tested for use with specific chemotherapy drugs. This device is not intended to be used as a chemical barrier.

The N-DEX® BWC™ 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.

This 510(k) submission describes the N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove (pink) and its substantial equivalence to a predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical examination glove, and its performance is evaluated against established ASTM standards and biocompatibility tests.

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

• Test Set Sample Size: The document does not explicitly state the sample sizes used for each ASTM standard test or biocompatibility study. However, these standards typically specify minimum sample sizes for testing to achieve statistically significant results.
• Data Provenance: The studies were conducted by Best Glove, Inc. and are considered retrospective in the sense that the data is presented to demonstrate conformance to existing standards rather than generated from a new clinical trial. The country of origin for the data is not explicitly stated, but given the company's US address and compliance with ASTM and ISO standards, it is highly likely the testing was performed in the US or in accredited labs adhering to international standards.

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

This type of submission for a medical glove does not involve establishing ground truth from human expert consensus in the way an AI diagnostic device would. Instead, ground truth for material properties is established by adherence to validated ASTM and ISO test methods performed in laboratories. The "experts" involved would be qualified laboratory technicians, engineers, and scientists specialized in materials testing and biocompatibility. Their qualifications would be based on their expertise in performing and interpreting these specific tests according to regulatory and industry standards.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. The conformance to standards is determined by objective laboratory measurements and interpretations of those results against the criteria defined by the respective ASTM and ISO standards. There is no ambiguous result that requires human adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. For a medical examination glove, the "effectiveness" is primarily determined by its physical properties and biocompatibility, as measured by standard laboratory tests, not by human reader performance.

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

Yes, the performance evaluation in this submission is effectively a "standalone" evaluation of the glove's physical and biological properties. The tests (ASTM for physical properties, ISO for biocompatibility) are objective measurements of the device itself, without any human-in-the-loop diagnostic or interpretive component.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Standardized Test Methods and Specifications: Conformance to specific ASTM and ISO standards (e.g., ASTM D 6319-00a for glove properties, ISO 10993 for biocompatibility). These standards define objective, measurable criteria for acceptable performance.
• Predicate Device Performance: The primary ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Ultimate N-DEX® Nitrile Powder-Free Medical Examination Glove, Non-Sterile (blue), K001375). The proposed device must meet or exceed the performance of the predicate device for relevant parameters.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" in the context of manufacturing would relate to process control and quality assurance to ensure consistent product attributes, not a data-driven training of a model.

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

Not applicable. As noted above, there is no AI/ML training set for this device.

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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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