Search Results

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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs. The subject devices are identical in design and formulation to the predicate gloves of K230121.

The provided FDA 510(k) clearance letter pertains to Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), a medical device. This type of device is classified as a Class I medical device and does not involve AI/ML technology. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods, effect sizes) are not applicable.

The acceptance criteria and device performance are primarily evaluated based on material properties, chemical permeation resistance, and biocompatibility, using established ASTM and ISO standards for examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device, "NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)", was tested against various physical, chemical, and biological criteria.

Detailed Chemotherapy Drug and Fentanyl Citrate Permeation Performance:

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

The document does not explicitly state the exact sample sizes for each test (e.g., number of gloves tested for permeation, holes, dimensions, etc.) but refers to adherence to the methodologies outlined in the specified ASTM and ISO standards. These standards typically define minimum sample sizes for material testing.

• Data Provenance: The document states the applicant is from Malaysia (Careglove Global Sdn. Bhd.). The testing was conducted according to international standards (ASTM, ISO), implying the tests were performed in a controlled laboratory environment, likely by the manufacturer or a contracted lab. The data is non-clinical and derived from prospective testing of manufactured glove samples.

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

Not applicable. This device is not an AI/ML device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" for material properties is established by the physical and chemical measurements themselves, according to standardized protocols and certified laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML device that requires adjudication for interpretations. Test results are objective measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are relevant for diagnostic or interpretive AI/ML devices where human readers' performance is evaluated with and without AI assistance. This is a physical and chemical barrier device.

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

Not applicable. This device is a passive physical barrier and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements of physical properties (e.g., length, thickness, tensile strength, elongation), chemical resistance (breakthrough detection time), and biological reactivity (biocompatibility tests), as defined by internationally recognized standards (ASTM, ISO). There is no subjective human "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes "training."

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

Not applicable. This is not an AI/ML device. The manufacturing process of the gloves is designed to meet the specified standards, and quality control ensures consistency, but this is not "training" in the context of AI/ML.

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.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate.

This document describes the testing for Nitrile Examination Gloves, focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. The study assesses the gloves' physical properties, biocompatibility, and chemical permeation alongside the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time)

Physical Properties, Dimensional, and Biocompatibility Testing

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

The document does not explicitly state the sample size (number of gloves) used for the permeation, physical property, or biocompatibility tests.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, the tests were conducted according to international standards (e.g., ASTM, ISO), which implies a standardized, prospective testing approach in a laboratory setting. The applicant is based in Malaysia.

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

Not applicable. This is not a study involving expert readers or ground truth established by medical professionals. The "ground truth" for this device is determined by objective, standardized laboratory measurements (e.g., chemical permeation time, physical properties, biological reactions) as defined by the referenced ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process involved as the "ground truth" is determined by objective laboratory measurements and adherence to specified test standards.

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 relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is examination gloves, and its performance is evaluated through physical, chemical, and biological testing, not by human readers interpreting cases.

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

Not applicable. This is a medical device (examination gloves), not an AI algorithm. Therefore, the concept of "standalone" performance for an algorithm does not apply. All listed tests are "standalone" in the sense that they assess the intrinsic properties of the glove without human intervention in the measurement process itself, though human technicians conduct and analyze the tests.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

• Performance Standards: Defined by international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (for physical properties and hole freedom), and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11 (for biocompatibility).
• Objective Laboratory Measurements: Direct measurements of breakthrough time, dimensional properties, tensile strength, elongation, residual powder, and biological response to the glove materials.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied in this submission, as the device is not an AI/ML algorithm that requires training data.

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

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

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

It is a powder-free chloroprene patient examination gloves made by on-line polymer-coating and mild on-line chlorination process. The process modifies the surface characteristics without the use of any dusting or donning powder. The gloves are non-sterile, disposable and for single use only.

Characteristics:

• Ambidextrous with beaded cuff
• Blended synthetic latex (Chloroprene and Nitrile Latex)
• Blue or green Coloured ●
• Five sizes: X-Small, Small, Medium, Large and X-Large. ●

The provided document is a 510(k) Premarket Notification for Chloroprene Examination Gloves Powder Free (Blue, Green). This document focuses on demonstrating substantial equivalence to a predicate device, which involves comparing material, design, and performance characteristics for a medical device (examination gloves), not an AI/ML-driven device.

Therefore, the requested information regarding AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this document.

What the document does provide is a detailed comparison of the physical and biological characteristics of the proposed gloves against established ASTM standards and the predicate device.

Here's a summary of the acceptance criteria and reported performance for the Chloroprene Examination Gloves Powder Free (Blue, Green), as extracted from the provided text:

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

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

• Sample Size: Not explicitly stated as a single "test set" sample size for a clinical study. The data presented are results of various laboratory and biocompatibility tests on the gloves. These tests typically involve a specific number of gloves or samples per test as per the ASTM and ISO standards referenced (e.g., AQL for water leak tests, specific batches for physical property tests). The exact number of gloves or samples for each test is not detailed in this summary, but the results confirm they "Meet" or "Pass" the specified standards.
• Data Provenance: The manufacturer is Careglove Global SDN BHD, located in Malaysia. The testing was conducted to comply with international standards (ASTM and ISO). The document does not specify whether the data is retrospective or prospective in the context of a clinical trial, as this is a premarket notification for a Class I general medical device based on engineering and biocompatibility testing.

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)

• Not Applicable. This is a physical medical device (examination gloves) where "ground truth" is established through adherence to standardized laboratory test methods (ASTM, ISO) for physical properties and biocompatibility, not by expert interpretation of medical images or patient outcomes.

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

• Not Applicable. As per point 3, this is a physical device tested against objective standards, not an AI/ML system requiring human expert 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 (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is based on objective measurements defined by international standards (ASTM D6977-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-10, ISO 10993-5, ISO 10993-11) for physical properties (e.g., length, thickness, tensile strength, elongation, freedom from holes, powder residue) and biocompatibility (e.g., skin irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. This is not an AI/ML device; there is no "training set" or establishment of ground truth in that context.

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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

This is a 510(k) summary for a medical device (Powder Free Nitrile Examination Gloves, Blue, Chemotest), not an AI/ML device. Therefore, the sections regarding AI/ML device assessment criteria (such as sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Here's the relevant information extrapolated from the document regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

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 explicitly state the sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, holes, or physical properties). However, it implies that the testing was conducted according to the specified ASTM and ISO standards, which would dictate appropriate sample sizes for each test method.

The data provenance is not explicitly stated in terms of country of origin of the testing data itself, but the applicant is Careglove Global SDN BHD from Malaysia. The studies are non-clinical, laboratory-based tests.

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

Not applicable, as this is for a physical medical device (examination gloves) and not an AI/ML diagnostic or predictive device requiring ground truth from human experts. The "truth" is established by physical measurement against standard specifications.

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

Not applicable. This concept applies primarily to AI/ML clinical studies where human readers might adjudicate discrepancies or define ground truth. For physical device testing, results are measured and compared against established 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, 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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" or reference values for device performance are defined by recognized international and national standards:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06 (Standard Test Method for Residue on Medical Gloves)
• ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
• ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
• ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
• ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)

The device's performance is compared directly to the specifications outlined in these standards.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device and therefore does not have a "training set."

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

Not applicable, as this is not an AI/ML device and therefore does not have a "training set" with established ground truth.

Ask a specific question about this device

A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.

The subject device is a powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

The provided document is a 510(k) summary for a medical device: "Sterile Latex Surgical Gloves, Powder Free." It details the device's characteristics, comparison to a predicate device, and the results of non-clinical testing. It explicitly states that clinical testing was "Not applicable." Therefore, the document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic or AI-based medical device performance study.

The questions in the prompt relate to the evaluation of an AI or diagnostic device, asking about sample sizes, expert ground truth, MRMC studies, and training sets. This information is not relevant to a 510(k) submission for surgical gloves, which are assessed based on physical properties, sterility, and biocompatibility.

However, I can extract the acceptance criteria and reported device performance for the surgical gloves based on the provided tables.

Here's the information derived from the document, tailored to the context of surgical gloves:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the specifications of ASTM D3577-15 and other relevant standards (ISO 11737-2, ISO 10993-10, ISO 10993-5, ISO 10993-11, USP General Chapter 40). The reported device performance indicates whether the subject device "Meets" or "Passes" these specifications.

Regarding the specific questions about an AI/diagnostic device evaluation:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable. The device is a surgical glove, not a diagnostic or AI device. The testing involved physical and chemical properties and biocompatibility, not patient data.

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 information is not applicable. Ground truth as understood in AI/diagnostic studies (e.g., disease presence) is not relevant for surgical gloves. The "ground truth" for the gloves are the established international standards for their physical, chemical, and biological properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are used in interpreting ambiguous diagnostic findings, which is not relevant for surgical gloves.

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:
This information is not applicable. MRMC studies are used to evaluate human reader performance with and without AI assistance in diagnostic tasks. This device is a surgical glove.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. Standalone algorithm performance is relevant for AI devices. This device is a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For surgical gloves, the "ground truth" is defined by adherence to recognized international standards (e.g., ASTM, ISO, USP) for physical properties, sterility, and biocompatibility. This involves laboratory testing using defined methodologies, not clinical outcomes data or expert diagnostic consensus.

8. The sample size for the training set:
This information is not applicable. Training sets are used for machine learning. This document describes testing of manufactured physical products, not an AI model.

9. How the ground truth for the training set was established:
This information is not applicable. There is no training set for a surgical glove.

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.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.

Based on the provided document, the device in question is Powder Free Nitrile Examination Gloves, Blue (colored). This document is a 510(k) Summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, many of the requested elements for an AI device (like human reader improvement with AI assistance, standalone performance, training set details, expert qualifications for ground truth) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria and performance data for the physical and biological characteristics of the gloves as presented in the "Summary of the Technological Characteristic" section.

Here's the breakdown:

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

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

The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, tensile strength, or water leaks). It simply states that the subject device "Meet[s]" or "Passes" the criteria. The provenance of the data is not explicitly stated beyond being presented in a submission from Careglove Global Sdn Bhd, Malaysia, implying the testing was conducted to support their device. It's standard for these types of tests to be prospective, laboratory-based evaluations.

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

Not applicable. This device is a physical product (examination gloves), not an AI-powered diagnostic tool requiring expert interpretation for "ground truth". The performance criteria are physical and chemical measurements or biological response assessments, not based on expert consensus.

4. Adjudication method for the test set:

Not applicable for the same reasons as #3. Quality control of physical properties does not typically involve expert 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 device.

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

Not applicable. This is not an AI device. The "standalone performance" is the inherent physical and chemical properties of the glove itself.

7. The type of ground truth used:

The "ground truth" for the physical and chemical properties of the gloves is established by standardized laboratory testing methods (e.g., likely conforming to ASTM standards like D6310, as mentioned in the document). For biocompatibility, the ground truth is established by the biological response observed in appropriate in vivo or in vitro models as per standard biocompatibility testing protocols.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI 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.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

The document is a 510(k) Premarket Notification for "Latex Examination Gloves Powder Free". It does not describe an AI/ML medical device, therefore, the requested information for acceptance criteria and study details for such a device is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K152593) for patient examination gloves.

However, I can extract the acceptance criteria and performance of the device based on the non-clinical tests mentioned, as they serve a similar purpose of demonstrating safety and effectiveness for this medical device.

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 explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, thickness, or tensile strength). However, the tests were performed "as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20." These standards typically define the sampling plans. The data provenance is Malaysia, as the applicant, Careglove Global SDN BHD, is located in Seremban, Negeri Sembilan, Malaysia. The tests are non-clinical and would be considered prospective in the sense that they were conducted specifically for this 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 not an AI/ML device that requires expert ground truth for image or data interpretation. The ground truth for the glove's performance is established by objective measurements against established industry standards (ASTM D3578-05).

4. Adjudication method for the test set
Not applicable, as it's not an AI/ML device requiring human adjudication of performance. The performance is determined by direct physical and chemical measurements.

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 based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-05 (Standard Specification for Rubber Examination Gloves)
• 21 CFR 800.20 (dealing with devices that prevent contamination)
• ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

These standards define the acceptable performance limits for the characteristics tested.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth for it. The ground truth for the device's performance is established by the aforementioned ASTM and ISO standards for physical characteristics and biocompatibility.

Ask a specific question about this device