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The NITRI-CARE Nitrile Powder-Free Sterile 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).

Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.

Acceptance Criteria and Study for NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove

The provided document describes the acceptance criteria and a study to demonstrate the substantial equivalence of the NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove to a predicate device (N-DEX Nitrile Powder-Free Medical Examination Glove, K992170). The focus of the substantiation is on the safety and performance characteristics, particularly concerning watertightness, irritation, and sensitization.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "The data summaries indicate that the proposed product meets or exceeds accepted scores for the predicate product in both nonclinical tests and satisfies the requirements for a safe and effective 'powder-free' medical glove." This implies that the proposed device's performance aligns with or is better than the predicate's according to the established acceptance criteria.

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

• Sample Size for Modified Draze Test (Human Study): 200 human subjects.
• Data Provenance: The document does not explicitly state the country of origin for the human study. The study appears to be prospective as it involved testing human subjects for the device's safety. The animal tests (Rabbit Irritation, Guinea Pig Sensitization) are also typically prospective.

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

The document does not specify the number of experts or their qualifications for establishing the "ground truth" (i.e., assessment of "Passes" for irritation and sensitization tests). These are standard biological evaluation tests whose interpretation would typically be performed by trained personnel in a testing facility, following established protocols for interpreting skin reactions.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Interpretation of animal and human skin patch tests often involves standardized grading scales and expert evaluation, but the submission doesn't detail any specific multi-reader adjudication process.

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

No MRMC comparative effectiveness study was conducted or is mentioned. The device is a medical examination glove, and its effectiveness is primarily assessed through barrier integrity (watertightness) and biological safety (lack of irritation/sensitization), not through efficacy in complex diagnostic or therapeutic tasks requiring human interpretation of data. Therefore, a study assessing human reader improvement with or without AI assistance is not applicable to this device.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was conducted or is mentioned. This device does not involve an algorithm or AI component. Its performance is based on its physical and chemical properties and biological safety.

7. Type of Ground Truth Used

The ground truth for the performance and safety tests is based on pre-defined pass/fail criteria for standardized tests:

• Performance (Watertightness): Adherence to ASTM standards, which specify methods and criteria for determining watertightness.
• Safety (Irritation/Sensitization - Animal & Human): Observation and grading of biological responses (e.g., skin reactions) against established criteria inherent in the "Passes" outcome for tests like Rabbit Irritation, Guinea Pig Sensitization, and Modified Draze Test. This aligns with physiological/biological response data interpreted against normative standards.

8. Sample Size for the Training Set

Not applicable. This device is a passive barrier (medical glove) and does not involve any machine learning algorithm that would require a "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no training set for this type of device.

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