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These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.

The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.

Here's a breakdown of the acceptance criteria and study information for the Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, as derived from the provided 510(k) summary:

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 testing each characteristic. However, the testing was done against established ASTM (American Society for Testing and Materials) standards. These standards typically specify appropriate sample sizes and testing methodologies. The data provenance is not explicitly mentioned regarding country of origin or whether it was retrospective or prospective, but it implies prospective testing conducted to meet the specified ASTM standards.

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

This information is not provided in the document. The "ground truth" for the device's performance is established by meeting the specified ASTM standards, which are objective, standardized tests for physical and chemical properties. These standards do not typically rely on "expert consensus" in the same way clinical diagnostic devices might.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The testing performed is objective and based on established ASTM methods, not on interpretation or consensus among experts.

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

An MRMC study was not conducted. The device is a surgical glove, and its effectiveness is measured by its physical properties and barrier protection, not by human reader interpretation of images or data.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not conducted. This concept is relevant for AI/software-as-a-medical-device. The device in question is a physical product (surgical gloves).

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" for this device is based on objective measurements and results from standardized laboratory tests according to ASTM and ISO standards. This includes:

• Physical measurements (e.g., dimensions, force at break).
• Chemical analysis (e.g., powder residue, protein content).
• Barrier integrity testing (e.g., freedom from holes, chemotherapy drug permeation).
• Biocompatibility assessments (dermal sensitization, primary skin irritation).

8. Sample Size for the Training Set:

This information is not applicable/provided. The device is a physical product, not an AI algorithm that requires a "training set." Manufacturing processes are designed to produce gloves meeting specifications, and quality control systems ensure adherence to these specifications.

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

This information is not applicable/provided for the reasons stated above.

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This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

The provided document is a 510(k) summary for medical gloves, and as such, it does not involve an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) are not applicable.

Here's an analysis based on the information available for this medical device (examination gloves):

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the sample sizes used for testing each characteristic. The data provenance is not explicitly stated in terms of country of origin but is based on performance tests against established ASTM and ISO standards for medical gloves. The tests are non-clinical.

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

Not applicable for this type of medical device (examination gloves). Ground truth is established by adherence to physical and chemical standards and biocompatibility tests, not by expert consensus in the same way as an imaging or diagnostic AI/ML device would require.

4. Adjudication method for the test set

Not applicable. Testing involves standardized measurement and laboratory procedures, not human adjudication of performance in a diagnostic sense.

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, as 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, as this is not an AI/ML device.

7. The type of ground truth used

The ground truth is based on the specifications outlined in several ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for medical examination gloves. These are objective, measurable criteria and test methods. Specifically:

• ASTM D 6319-00a(2005): Standard Specification for Nitrile Examination Gloves for Medical Application.
• ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
• ISO standards for biocompatibility: (specific standard numbers not provided, but mentioned as "ISO Skin Irritation Study" and "ISO Maximization Sensitization Study - Extract").

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. There is no "training set" in the context of physical product testing for medical gloves.

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

Not applicable.

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This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each test (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Primary Skin Irritation, Guinea Pig Sensitization). However, it implies that the testing was conducted according to the methodologies outlined in the referenced ASTM standards (ASTM D 6319-00ae3 and ASTM D 5151-99), which would specify sample sizes.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. Given the context of a 510(k) summary for a medical device seeking market clearance in the US, the testing would typically be conducted by the manufacturer or a contracted lab to generate prospective data for regulatory submission.

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

This information is not applicable to the present submission. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not against "ground truth" established by clinical experts interpreting data.

4. Adjudication method for the test set

This information is not applicable for this type of device and testing. The performance is objectively measured against predefined 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves are a physical barrier device, and their performance is assessed through laboratory testing against engineering and biological standards, not through clinical interpretation by human readers.

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

This question is not applicable. The device is a physical glove, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" in this context is the established performance requirements and methodologies detailed in the referenced ASTM standards:

• ASTM D 6319-00ae3: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D 5151-99: Standard Test Method for Detection of Holes in Medical Gloves

For biocompatibility, the "ground truth" is defined by the "Passes" criteria for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, which are standard biological tests for medical devices.

8. The sample size for the training set

This information is not applicable. The device is a manufactured product, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for this device.

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Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

This document describes the acceptance criteria and performance of the Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol.

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance

The device, "Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol," is a medical examination glove. Its acceptance criteria and reported performance are based on its compliance with established ASTM standards and additional biocompatibility tests.

Acceptance Criteria and Reported Device Performance Table:

Study Details for Device Performance

Based on the provided document, the device's performance is demonstrated through adherence to recognized industry standards, primarily ASTM D 3578-01a€2 and ASTM D 5151-99, along with specific biocompatibility tests.

1. 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 the exact sample sizes used for testing each characteristic (e.g., number of gloves tested for dimensions, holes, etc.).
• The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. However, the tests are performed to demonstrate compliance with ASTM standards, which are generally established protocols.

2. 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 to this type of device and study. The "ground truth" for glove performance is determined by established engineering specifications and chemical testing protocols outlined in the ASTM standards and biocompatibility tests, not by expert consensus on interpretation.

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

• Not applicable. Performance is determined by objective measurements against quantitative or qualitative pass/fail criteria defined by the ASTM standards and biocompatibility tests.

4. 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/imaging device.

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

• Not applicable. This is a physical medical device (examination glove), not an algorithm. The performance is inherent to the product's physical and chemical properties.

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

• The "ground truth" for this device is based on established engineering and material science specifications as defined in the ASTM standards (D 3578-01a€2 for general examination glove requirements, D 5151-99 for freedom from holes) and standardized biological testing protocols for biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These standards specify the methods and criteria for determining whether the glove meets the necessary performance and safety requirements.

7. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of demonstrating compliance for such a product.

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

• Not applicable, as there is no training set for this type of device. The specifications used to design and manufacture the gloves would be based on the requirements of the ASTM standards, and their performance is verified through testing against those standards.

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Ultralon® Powder Free Latex Surgical Gloves are to be worn by operating room personnel to protect a surgical wound from contamination.

Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.

This report describes the acceptance criteria and study proving the performance of Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify a separate "test set" in the context of clinical trials as clinical data were deemed not needed. The product's performance was evaluated against established ASTM standards through non-clinical testing. The sample sizes for these non-clinical tests (e.g., for dimensions, physical properties, freedom from holes, biocompatibility, and protein content) are not explicitly stated in this summary. The data provenance is non-clinical laboratory testing performed by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable, as the acceptance criteria are based on established ASTM standards and non-clinical laboratory testing, not on expert consensus from clinicians for a specific test set.

4. Adjudication Method for Test Set

Not applicable. The evaluation was based on meeting pre-defined ASTM standards through laboratory testing.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data are not needed for medical gloves or for most devices cleared by the 510(k) process."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical product (surgical glove), not an algorithm or a device with an AI component requiring standalone algorithm performance evaluation.

7. Type of Ground Truth Used

The "ground truth" for the device's performance relies on:

• Established ASTM Standards: For dimensions, physical properties, freedom from holes (ASTM D 3577-00 and ASTM D 5151-99).
• Established Biocompatibility Tests: Guinea Pig Sensitization and Primary Skin Irritation in Rabbits.
• Established ASTM Standard for Protein Analysis: ASTM D 5712-99 for the protein label claim.

8. Sample Size for Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device evaluated against pre-defined standards, not a machine learning model.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination.

Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.

The provided text describes the acceptance criteria and a study for the "Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim)". However, it's important to note that this is a 510(k) submission from 2001 for a physical medical device (surgical gloves), not an AI/ML software device. Therefore, many of the requested fields (like sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted or inferred from the document based on the provided categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable for this type of medical device submission. The "tests" refer to standardized physical and chemical property tests, not a "test set" in the context of an AI/ML algorithm. The ASTM standards specify testing methodologies and sample sizes for quality control, but this document summarizes the results of meeting those standards.
• Data Provenance: Not applicable in the AI/ML sense. The non-clinical test data was generated by Ansell Healthcare Products Inc. to demonstrate adherence to established ASTM standards. The specific country of origin for the test execution is not mentioned, and it's not "retrospective or prospective" data in the way a clinical study would be.

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

• Not applicable. For this type of physical device, ground truth is established by objective measurements against recognized industry standards (ASTM). No human expert consensus for "ground truth" (in the AI/ML sense) is involved.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, often in clinical imaging or diagnostics. The tests for surgical gloves are objective, laboratory-based measurements against defined 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

• No. An MRMC study is not relevant for this physical medical device. This type of study assesses the impact of AI on human reader performance, which doesn't apply to surgical gloves.

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

• Not applicable. This device is a physical product (surgical gloves), not an algorithm. Therefore, "standalone performance" of an algorithm is not relevant.

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

• The "ground truth" in this context is defined by established objective measurements and performance criteria specified in the referenced ASTM standards (ASTM D 3577-00 for dimensions, physical properties, freedom from holes; ASTM D 5151-99 for freedom from holes; ASTM D 5712-99 for protein analysis) and biocompatibility tests (Primary Skin Irritation in Rabbits Test, Guinea Pig Sensitization Test). This is a form of objective standard compliance.

8. The sample size for the training set

• Not applicable. There is no "training set" for physical medical devices of this nature. This concept is specific to machine learning algorithms.

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

• Not applicable. As there is no training set, this question is irrelevant.

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Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Here's a breakdown of the acceptance criteria and the study details for the "Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves," based on the provided 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 explicitly state the sample size used for each specific test within ASTM D 6319-00 or ASTM D 5151-99. These are standardized tests, and the sample sizes are dictated by the respective ASTM standards themselves. The data provenance is not specified beyond being generated by Ansell Healthcare Products Inc., implicitly in the USA. The data would be considered prospective as it's generated specifically for the clearance of this device.

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 document. For these types of medical devices (gloves), the "ground truth" is typically established by physical and chemical testing against recognized industry standards (ASTM standards), rather than by expert consensus on observational data. The standards themselves define the acceptable parameters.

4. Adjudication Method for the Test Set

This information is not applicable in the context of these physical and chemical tests. The "ground truth" is determined objectively by the test results themselves against the pre-defined criteria in the ASTM standards. There is no need for human adjudication of test results in the way it might be applied to image interpretation or clinical outcomes.

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 not relevant for medical examination gloves which are evaluated based on their physical properties, freedom from holes, and biocompatibility, not on interpretive clinical judgments by human readers.

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

No, a standalone study was not done. This device is a physical product (medical glove), not an algorithm or AI system. Therefore, the concept of "algorithm only" performance is not applicable.

7. The Type of Ground Truth Used

The ground truth used is primarily objective measurements against established industry standards (ASTM D 6319-00 and ASTM D 5151-99), along with biocompatibility test results.

8. The Sample Size for the Training Set

This information is not applicable. Since this is a physical medical device and not an AI or machine learning model, there is no "training set."

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

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

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device