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The N-DEX 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. Powder-free examination gloves are suitable in situations where powder is not desirable.

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. The proposed device has no donning powder - this has been replaced by a polyurethane base coating, which is fully cross linked with the nitrile film. The proposed device is labeled "Powder-Free".

The information provided describes the N-DEX Nitrile Powder-Free Medical Examination Glove and its acceptance criteria, particularly focusing on how it compares to a predicate device.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: For the clinical safety tests, the predicate device's specific acceptance criteria (e.g., "Passes") are implied as the proposed device is compared against it and also "Passes." The document states the proposed device “meets or exceeds accepted scores for the predicate product.”

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

• Sample Size: For the Modified Draze Test (human study), 200 human subjects were used.
• Data Provenance: The document does not explicitly state the country of origin for the human subjects, nor does it specify if the study was retrospective or prospective. Given it's a pre-market submission for a new product, it's highly likely to be a prospective study conducted specifically for this submission.

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

• This information is not provided in the given text. The Modified Draze Test involves human subjects and observed reactions, but there's no mention of a ground truth established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

• This information is not applicable as the described tests are for material safety and performance, not for diagnostic accuracy requiring adjudication of expert interpretations.

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

• No, an MRMC comparative effectiveness study was not done. The study is focused on the device's physical performance, watertightness, and safety (irritation/sensitization) in comparison to a predicate device, not on diagnostic accuracy involving human readers.

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

• This question is not applicable as the device is a medical examination glove, not an algorithm or AI system. Its performance is assessed directly through physical and biological tests.

7. The Type of Ground Truth Used:

• For the non-clinical tests (Performance Standards, Watertightness), the "ground truth" is defined by industry standards (ASTM) and regulatory requirements (FDA).
• For the clinical safety tests (Rabbit Irritation, Guinea Pig Sensitization, Modified Draze Test), the "ground truth" is established by observed biological responses (e.g., absence of irritation or sensitization) in the test subjects, as per the methodologies described in the respective test standards.

8. The Sample Size for the Training Set:

• This question is not applicable as the device is a physical product (medical examination glove) and does not involve a "training set" in the context of machine learning or algorithms.

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

• This question is not applicable for the same reason as #8.

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