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The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided text describes a 510(k) summary for a medical device called "Blue Nitrile Exam Glove, Powder Free" (K210057). This document focuses on demonstrating substantial equivalence to a predicate device (K171422) rather than conducting a standalone study to prove acceptance criteria for a novel device. Therefore, many of the requested categories related to a detailed study on performance, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, and ground truth for training sets, are not applicable in this context.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting established ASTM and ISO standards for examination gloves. The "reported device performance" is essentially the statement that the device complies with these standards and the listed physical property values.

2. Sample size used for the Test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of a dataset for an AI/algorithm, as the device is a physical product (medical glove). The "tests" mentioned are non-clinical standard conformance tests (e.g., physical property testing, biocompatibility).

• Sample Size: The sample sizes for each specific standard test (e.g., number of gloves for tensile strength, number of gloves for hole detection) are not explicitly stated in this summary but would be defined by the respective ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151).
• Data Provenance: Not specified, but the testing was conducted to verify compliance with international standards (ISO, ASTM). The manufacturer is in China (Real Star Medical Technology Co., Ltd. in Dongying, China).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the device is a physical product (medical glove) and the evaluation involves standard physical and chemical testing, not clinical diagnosis by experts or expert consensus on image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The evaluation relies on meeting objective criteria defined by recognized standards (ASTM, ISO), not on subjective interpretation requiring 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 a medical glove, not an AI diagnostic or assistance device.

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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance claims is defined by the objective measurement criteria and thresholds established within the referenced international standards (ASTM D6319-19, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, ISO 10993-5:2009). For example, "Tensile Strength (Before Aging) $\ge$ 14MPa" is a ground truth established by the ASTM D6319-19 standard.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device. The device's manufacturing processes are subject to quality system regulations, but this is distinct from "training data" for an algorithm.

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

Not applicable.

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The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for a Blue Nitrile Exam Glove, Powder Free. It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or therapeutic product. Therefore, it does not contain the information required to answer the specific questions related to acceptance criteria, test sets, expert involvement, MRMC studies, or training sets for such a device.

The document primarily focuses on demonstrating that the subject device (the new glove) is "as safe, as effective, and performs as well as or better than" a predicate device (an existing glove) based on non-clinical testing of physical properties and biocompatibility.

Here's how the provided information relates to acceptance criteria, but note it's for a physical medical device (glove) and not an AI system:

1. A table of acceptance criteria and the reported device performance

The document provides tables ("Table3 Performance Comparison" and "Table4 Safety Comparison") that effectively function as a comparison of the subject device's performance against the predicate device, which implies certain performance acceptance criteria are met (i.e., being equivalent or better than the predicate, which itself met standards).

Here's an interpretation of the performance and safety "acceptance criteria" and "reported device performance" based on the provided tables:

2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes for these tests (e.g., how many gloves were tested for tensile strength or holes). It refers to standard test methods (e.g., ASTM D6319, ASTM D5151), which would define the sample sizes for those tests. The data provenance is implied to be from the manufacturer's own testing facilities in China ("Great Harvest Trading Co., Ltd." in Shandong, China). The testing is non-clinical, not retrospective or prospective in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical glove, not an AI system requiring expert consensus on medical images or diagnoses. The "ground truth" here is objective physical and chemical measurements (e.g., direct measurement of strength, elongation, hole presence, chemical content).

4. Adjudication method for the test set
Not applicable. The tests are standard objective measurements, not subjective human assessments requiring 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-based diagnostic 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-based diagnostic device.

7. The type of ground truth used
The ground truth for this device's performance is established by objective physical and chemical testing standards, such as ASTM D6319 for physical properties, ASTM D5151 for holes, ASTM D6124 for powder content, and ISO 10993 for biocompatibility. These are laboratory measurements, not expert consensus, pathology, or outcomes data in the medical imaging/diagnosis context.

8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of an AI/ML model.

9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.

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The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Exam Glove, Powder-Free Model Color White, Blue

This document is a 510(k) clearance letter from the FDA for a Nitrile Exam Glove. It does not contain information about the acceptance criteria or a study that proves a device meets such criteria, as it is for a low-risk device (Class I) that typically does not require extensive clinical studies or performance acceptance criteria beyond established standards for gloves (e.g., integrity, barrier protection).

Therefore, I cannot extract the requested information from the provided text.

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Ask a specific question about this device

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Exam Gloves, Powder-Free, Blue

This document is a 510(k) summary for a Nitrile Exam Glove, Powder-Free, Blue. It is a medical device submission, and the content provided does not relate to an AI/ML powered device or a study demonstrating its performance. Therefore, I cannot fulfill your request for detailed information about acceptance criteria, study design, and AI-specific metrics like MRMC studies or human reader improvement, as these concepts are not applicable to the provided document.

The document discusses the substantial equivalence of the Nitrile Exam Glove to already marketed devices based on physical characteristics and intended use. The "Test Results" section (K980802 on page 34 of 34) lists the standards and tests that the device has met or exceeded, which serve as the acceptance criteria for the glove's performance.

Here's a breakdown of the information that can be extracted relevant to your request, adapted for a non-AI medical device submission:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample sizes used for each test. For medical devices like gloves, testing is typically done on representative batches according to the specified ASTM standards.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted on the manufacturer's product (Sinochem Ningbo Latex Gloves Factory). The document does not specify country of origin for the data itself, but the device is manufactured by Sinochem Ningbo Latex Gloves Factory, implying the testing was done on their product. It is a retrospective evaluation of the product's compliance with established standards.

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

• This concept is not directly applicable to the testing of examination gloves. The "ground truth" here is adherence to objective, standardized test methodology and performance thresholds defined by organizations like ASTM and the FDA. The experts involved would be the certified laboratory technicians and engineers performing these specific tests, adhering to the standard protocols. Their qualifications would be in laboratory practices and materials testing, not medical diagnosis or interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Performance testing for medical gloves involves objective measurements against predefined standards, not subjective interpretations requiring 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:

• The "ground truth" is defined by the objective performance criteria specified in the referenced ASTM standards and FDA guidelines (e.g., specific tensile strength, elongation, water leak rate, biocompatibility thresholds).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of standard physical and biocompatibility testing for medical gloves.

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

• Not applicable.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Exam Gloves, Powder-Free

The provided document describes the acceptance criteria and the study results for the "Nitrile Exam Gloves, Powder-Free" manufactured by Ningbo Yujiang Plastic & Rubber Co. Ltd. This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving efficacy through a controlled clinical trial against specific disease outcomes.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test (ASTM D 3578-95, ASTM D 5151, FDA Water Leak Test, etc.). It only states that the device "met or exceeded" the requirements of these standards. The data provenance is not explicitly mentioned with respect to country of origin, but it is implied to be from testing conducted by or for Ningbo Yujiang Plastic & Rubber Co. Ltd. to meet US FDA requirements. The tests are general laboratory analyses, not human clinical trials, so the terms "retrospective" or "prospective" are not applicable in the typical sense.

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

Not applicable. For this type of device (nitrile exam gloves), "ground truth" is established by adherence to established engineering and material performance standards (e.g., ASTM standards) and biocompatibility tests, not by expert consensus on clinical images or patient outcomes. The "experts" involved would be relevant laboratory technicians and engineers performing and interpreting the results of these standardized tests. Their qualifications are implicitly that they are certified or trained to perform such tests according to the specified standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against defined pass/fail criteria within established standards. There is no need for human adjudication in the sense of resolving conflicting interpretations of complex data like in a clinical trial.

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 device is not an AI-powered diagnostic tool, but rather a medical glove. Therefore, an MRMC study and the concept of AI assistance for human readers are irrelevant.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device (gloves).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry standards and regulatory tests. These include:

• ASTM D 3578-95: Standard Specification for Rubber Examination Gloves
• ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves
• FDA Water Leak Test: A regulatory requirement for medical gloves.
• Bio-Compatibility Tests: (e.g., Dermal Sensitization, Primary Skin Irritation) to assess biological safety.
• Bio-Burden (bacteria/mold) Test: To assess the microbial load.

These standards define the acceptable physical properties, barrier integrity, and biological safety of the gloves.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set." The device performance is assessed directly against predefined standards.

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

Not applicable. There is no training set for this type of medical device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Exam Gloves, Powder-Free, White

The provided text describes a 510(k) submission for "Nitrile Exam Gloves, Powder-Free, White." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance criteria through a clinical trial or algorithm-based assessment. Therefore, many of the requested categories for AI/algorithm-driven device studies are not applicable.

Here's an analysis based on the provided text, with explanations for non-applicable criteria:

Acceptance Criteria and Device Performance for Nitrile Exam Gloves, Powder-Free, White

This submission pertains to a medical glove, a Class I device, and therefore the "acceptance criteria" are related to established physical and biocompatibility standards for such devices, rather than performance metrics for an AI algorithm. The "study" refers to a series of tests against these standards.

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 in the provided text for each test. General reference to "Test Results (Means and/or Results)" suggests samples were tested according to standard protocols for each criterion.
• Data Provenance: Not specified, but implied to be from laboratory testing of the manufactured gloves. The country of origin of the data is not mentioned. It is prospective testing of the device for submission.

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

• Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth for a test set. The "ground truth" is defined by the established ASTM and FDA standards for glove performance.

4. Adjudication method for the test set

• Not Applicable. As per point 3, there's no diagnostic decision or interpretation requiring adjudication. Performance is measured objectively against predefined thresholds in the standards.

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-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used

• Objective Standards: The "ground truth" is defined by the established, published standards and test methods from ASTM and the FDA (e.g., ASTM D 3578-95, ASTM D 5151, FDA Water Leak Test, Bio-Compatibility tests assessing specific biological reactions). These standards set the minimum acceptable performance metrics for the glove.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML algorithm that requires a training set. The manufacturing process of the gloves is designed to meet the standards, not "trained" on data.

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

• Not Applicable. As per point 8.

Summary Notes:

The provided document is a 510(k) summary for a relatively low-risk medical device (Class I), focusing on demonstrating substantial equivalence to a legally marketed predicate device. The "proof" that the device meets acceptance criteria comes from laboratory testing against established governmental and industry standards for its physical and biocompatibility properties. The framework for AI/ML device evaluation does not directly apply here.

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