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This 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.
The Nitrile Powder-Free Medical Examination Glove (blue) 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.

The provided document describes a 510(k) submission for Blue Nitrile Powder-Free Medical Examination Gloves. This submission is for a medical device and not an AI/ML powered device, so several of the requested categories (e.g., MRMC studies, training set details, expert qualifications for AI ground truth) are not applicable.

Here's an analysis of the acceptance criteria and study data 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

The document does not explicitly state the sample size for physical performance tests (like watertightness or general performance standards). For the safety tests (rabbit irritation and guinea pig sensitization), it indicates that the device "Passes" without providing specific sample sizes.

• Test Set Sample Size: Not explicitly stated for performance tests. Not explicitly stated for safety tests, but the results are reported as "Passes" which implies a sufficient sample was used to meet the passing criteria for the relevant tests.
• Data Provenance: The studies were conducted by Best Manufacturing Company (USA) for a device intended for the US market. The document does not specify if the safety tests involved retrospective or prospective data collection, but given they are animal studies, they would be prospective.

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

This is not applicable as the device is a physical medical examination glove, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on a test set. The "ground truth" for this device relies on objective, standardized physical and biocompatibility testing.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in AI/ML studies to establish ground truth or resolve disagreements. Here, the "truth" is determined by objective laboratory measurements and biological reactions (e.g., passing a rabbit irritation test).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are used to evaluate diagnostic performance, often for AI-assisted image analysis. This submission is for a physical medical device (glove) and does not involve human readers or AI assistance in diagnostic tasks.

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

This is not applicable. This submission is for a physical medical examination glove, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective, standardized laboratory measurements and animal biocompatibility test results, as defined by ASTM standards for physical properties and established protocols for safety tests like rabbit irritation and guinea pig sensitization.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "development" of the glove is based on materials science and manufacturing processes, culminating in testing against established standards.

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

This is not applicable, as there is no training set for this type of medical device.

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This 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.

The Nitrile Powder-Free Medical Examination Glove (green) 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.

The provided text describes a 510(k) submission for a Green Nitrile Powder-Free Medical Examination Glove. This is a medical device, and the submission's purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical efficacy through the types of studies typically associated with AI/ML devices. Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For examination gloves, the primary performance criteria relate to barrier integrity, safety (biocompatibility), and physical properties. The document indicates adherence to ASTM standards for physical performance and includes biocompatibility testing.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for specific tests like watertightness or biocompatibility. However, these are typically performed on representative samples according to the relevant ASTM standards.
• Data Provenance: Not specified; likely laboratory testing conducted by or for the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For examination gloves, performance is assessed through standardized physical and chemical tests, not through expert-labeled ground truth like in AI/ML image analysis.

4. Adjudication method for the test set

Not applicable. The "ground truth" for the performance characteristics of medical examination gloves is determined by objective, standardized tests, not by expert consensus or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the safety and performance aspects:

• Watertightness and Performance Standards: Objective measurements against American Society for Testing and Materials (ASTM) standards.
• Safety (Biocompatibility): Established "Pass/Fail" criteria based on animal testing (Rabbit Irritation, Guinea Pig Sensitization) as per biocompatibility guidelines.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set" in the context of developing this type of medical examination glove.

9. How the ground truth for the training set was established

Not applicable.

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The Green 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).

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 provided document describes a 510(k) submission for a medical examination glove, which is a low-risk device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than extensive clinical studies with complex acceptance criteria and ground truth establishment typically seen for higher-risk devices or AI/ML-driven diagnostics.

Therefore, many of the requested categories are not applicable or do not have direct equivalents in this type of submission.

Here's an analysis based on the provided text, indicating where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as this is a non-clinical, performance-based comparison to a predicate device, not a human reader study or clinical trial with a defined "test set" in the context of diagnostic accuracy.
• Data Provenance: The data refers to "Non-clinical tests (Human Study)" (referring to aspects like rabbit irritation and guinea pig sensitization, which use animal models, not human subjects for testing the glove's barrier properties or direct clinical performance). The provenance is best manufacturing company and not a country of origin. This is retrospective in the sense that the test results for the predicate are already established, and the proposed device is being evaluated against those established results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This submission does not involve human expert interpretation of data to establish a "ground truth" for diagnostic purposes. The ground truth for glove performance is established by standardized ASTM tests and animal safety models.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method in the context of expert review for diagnostic agreement as this is not a diagnostic device or a clinical study involving human judgment on cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a medical examination glove, not an AI-assisted diagnostic device. Therefore, no MRMC study with human readers and AI assistance was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm or software. Therefore, no standalone algorithm performance was assessed.

7. The type of ground truth used

• Standardized Performance Metrics: The "ground truth" is defined by established ASTM (American Society for Testing and Materials) standards for watertightness and "Performance Standards," as well as results from standardized biocompatibility tests (Rabbit Irritation, Guinea Pig Sensitization, Modified Draze Test). These are objective, laboratory-based measurements rather than expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set. The "training" for this device comes from the established manufacturing processes and material science, and its substantial equivalence is based on direct comparison to an already approved device.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set involved, the concept of establishing ground truth for it does not apply.

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The Nitrile Powder-Free Medical Examination Glove (brown) 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.

The provided document is a 510(k) submission for a medical examination glove, which is a low-risk device. The regulatory requirements for such devices typically focus on demonstrating substantial equivalence to a predicate device through non-clinical and, in some cases, limited clinical testing, rather than extensive studies with acceptance criteria, human reader performance, or detailed ground truth establishment as would be required for more complex diagnostic AI devices.

Therefore, many of the requested categories for AI-based device studies are not applicable to this submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical and limited clinical (biocompatibility) comparison study against two predicate devices: N-DEX Nitrile Powder-Free Medical Examination Glove (K992170) and HPI Brown Nitrile Surgical Glove (K915086). The submission claims that the proposed device "meets or exceeds accepted scores for the predicate product in both physical and non-clinical tests."

Detailed Information for AI-based Device Categories (Not Applicable / Information Not Provided for this Medical Glove Submission):

• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the glove material itself, subjected to physical and chemical tests (e.g., for watertightness, irritation). The document doesn't specify the number of gloves sampled for these tests, nor the "country of origin of the data" in the context of user data. This is a medical device, not a data-driven AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical medical device like this is established through standardized test methods (e.g., ASTM standards for glove performance, animal/human studies for biocompatibility). It doesn't involve expert consensus on image interpretation or similar AI-related tasks.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by standardized physical tests (e.g., ASTM for watertightness, tensile strength - though tensile strength isn't explicitly listed in the summary table but implied by "performance standards") and biocompatibility testing using animal models (rabbit irritation, guinea pig sensitization) and a human study for skin sensitivity (Modified Draze Test on the predicate).
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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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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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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