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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.

This document describes the acceptance criteria and performance of the "POWDER-FREE, 'BARRIER-PRO™, SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN" manufactured by Shield Gloves, as submitted for 510(k) clearance (K011613).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The device explicitly states that it meets/exceeds ASTM-D3578 Standard Specifications for Latex Examination Gloves, except for the elongation at break parameter. However, the provided tables show that the "Ultimate Elongation" for the Shield Gloves exceeds the ASTM-D3578-00 requirement for both before and after aging. This might be a misunderstanding of the "elongation at break parameter" or an older ASTM standard being referenced in the summary text. Based on the provided table, the performance for Ultimate Elongation is better than the ASTM standard.

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

• Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested specifically for the water leak test (4 sizes * 125 gloves/size * 2 aging conditions).
• Tensile Strength & Ultimate Elongation: The data is reported for each size (X-Small, Small, Medium, Large) for both before and after aging. The specific number of samples tested for these mechanical properties is not explicitly stated, but it is reported for "Lot# 1128".
• Residual Powder Content: The range (0.7-1.5mg/glove) and mean (1.05 mg/glove) suggest multiple samples were tested, but the total sample size is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Shield Gloves Manufacturing (M) Sdn Bhd is the applicant and is located in Malaysia (implied by "Sdn. Bhd." and context), it is highly likely the testing was conducted by or for the manufacturer, presumably in Malaysia, as part of their product development and regulatory submission. The testing would be considered prospective for the purpose of this 510(k) submission.

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

Not applicable. This device is a medical glove, and its performance is evaluated against engineering and material standards (e.g., ASTM D3578) and regulatory requirements (e.g., FDA water leak test, biocompatibility, powder content). Ground truth is established by these objective standards and tests, not by expert interpretation of clinical images or subjective assessments typically requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., in clinical trials or image interpretation) where multiple experts might disagree on an outcome. For objective physical and chemical tests of a medical glove, the results are typically quantitative measurements or pass/fail criteria based on defined standards, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical medical glove and does not involve AI or human "readers" in its intended use or evaluation.

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

Not applicable. This device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most of the performance criteria is based on established industry standards and regulatory requirements:

• ASTM-D3578-00/99: "Standard Specification for Latex Examination Gloves for Medical Application" (for Dimension, Tensile Strength, Ultimate Elongation).
• FDA specified water leak test: A specific methodology for determining watertight integrity.
• Biocompatibility standards: Tests for dermal irritation and skin sensitization.
• ASTM D 6124-00: For Residual Powder Content.
• FDA claim criterion: For a powder-free glove (presence of cornstarch).

These standards define the objective and measurable criteria for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of physical goods involves quality control and process validation, which might use statistical sampling (e.g., during production runs) but is distinct from an AI training set.

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

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

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance data for ROYAL SHIELD BLUE COLORED POWDERED LATEX EXAMINATION GLOVES. This document does not pertain to an AI-powered device or software for medical imaging analysis. Therefore, many of the requested points, such as those related to AI effectiveness, ground truth establishment for AI, expert qualifications, and training/test sets for algorithms, are not applicable.

Here's the information that can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Test Set and Data Provenance

• Physical Properties (Tensile Strength & Ultimate Elongation): The table shows 3 data points for each measurement, implying at least 3 samples were tested.
• Watertightness:
  • Batch 9028-9035 S: 315 samples
  • Batch 9030-9036 M: 315 samples
  • Batch 9027-9031 L: 200 samples
• Data Provenance: The country of origin for the data is not specified, but the manufacturer is "Shield Gloves Manufacturer (M) Sdn. Bhd.", suggesting an origin outside the US (Sdn. Bhd. is a Malaysian company type). The data appears to be prospective testing performed on the manufactured gloves to demonstrate compliance before market release.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This document describes physical and chemical testing of a medical device (gloves), not an AI system requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. The tests performed are objective measurements following standard ASTM methods or biological tests, not subjective interpretations requiring adjudication.

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

• Not applicable. This relates to human reader performance with and without AI, which is irrelevant for a latex glove.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This relates to the performance of an AI algorithm on its own, which is irrelevant for a latex glove.

7. Type of Ground Truth Used

• Objective Measurements and Standardized Tests: The "ground truth" for the glove's performance is established through:
  • Direct physical measurements (dimensions, thickness).
  • Mechanical stress tests (tensile strength, elongation) conforming to ASTM standards.
  • Defined leak test protocols.
  • Biocompatibility tests (dermal irritation, sensitization) following established methodologies.
  • Chemical analysis (residual protein level) using ASTM D 5712-95.
    These are all objectively quantifiable and do not rely on expert consensus or pathology in the typical sense of medical imaging.

8. Sample Size for the Training Set

• Not applicable. The concept of a "training set" applies to machine learning algorithms, which are not described here.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no AI training set.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance data for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES, rather than a typical AI-driven device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, etc.) are not applicable to the documentation provided for this type of medical device clearance.

However, I can extract the relevant information regarding acceptance criteria and reported performance from the document.

Acceptance Criteria and Reported Device Performance for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's compliance is demonstrated through a series of tests against established standards, primarily ASTM-D3578-99 and FDA requirements.

• Dimensional Testing: The provided table shows that the Royal Shield Powdered Latex Examination Gloves meet the specified width, length, and thickness dimensions across various sizes.
• Physical Properties (Tensile Strength & Ultimate Elongation): Data from gloves produced in 1994, tested after "Real Time Ageing" in 1997, 1998, and 1999, demonstrates performance that "meets/exceeds ASTM-D3578-95 Standard Specifications." The reported tensile strength and ultimate elongation values for both aged and unaged gloves are significantly higher than the ASTM acceptance criteria.
• Water Tight Test (Pinhole Requirements): A 1,000 ml water leak test (FDA specified) was conducted on 80 pieces (batch #9410243147/9411153155, Size L/R 6.0) of gloves produced in 1994. Tests were performed on March 10, 1997 (125 samples), March 10, 1998 (125 samples), and March 11, 1999 (125 samples). The number of leaked gloves was 2, 1, and 2 respectively. These figures are stated to be "within the FDA/draft ASTM requirements for latex exam gloves of 2.5% AQL," indicating compliance with pinhole requirements. This also supports the "SHIELD's shelf life labeling claim of four years."
• Biocompatibility: Tests for Primary Dermal Irritation and Skin Sensitization indicated that the gloves are "Not a primary irritant" and "Not a sensitiser," respectively, meeting FDA biocompatibility requirements.
• Residual Protein Level: Testing using ASTM D 5712-95 showed a claimed level of "< 200 µg/g" of protein, which meets the device's labeling claim.

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

• Test Set Sample Size:
  • Water Tight Test: 125 gloves were tested on each of three separate occasions (total of 375 gloves over the multi-year study for this specific test). The text also states "80 pieces of the gloves produced in 1994 over a period of three years of storage were tested," which seems to contradict the 125 samples per test. However, the table explicitly lists 125 samples for each of the three water leak tests. Given the explicit table data, assuming 125 samples per water leak test.
  • Physical Properties: The number of gloves tested for tensile strength and ultimate elongation is not explicitly stated in the provided text, but the results are for "gloves produced in 1994" and tested annually over three years.
  • Biocompatibility & Residual Protein: Sample sizes are not specified.
• Data Provenance: The data is "After Real Time Ageing On Gloves Produced in 1994." This indicates a retrospective analysis of gloves stored over time. The company (Shield Gloves Manufacturer (M) Sdn. Bhd.) is based in Malaysia, suggesting the origin of testing and manufacturing data.

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

• N/A. This device clearance is for a physical medical product (gloves) and does not involve image interpretation or diagnostic algorithms where expert ground truth is typically established. The "ground truth" here is defined by objective physical and chemical testing standards (ASTM, FDA).

4. Adjudication Method for the Test Set:

• N/A. Not applicable for this type of device testing. Performance is measured against quantitative standards.

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

• N/A. This is not an AI-driven or diagnostic device; therefore, an MRMC study is not relevant.

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

• N/A. Not applicable, as this is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device is based on established industry standards and regulatory requirements, specifically:
  • ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.
  • FDA specified 1,000 ml water leak test (for AQL/pinholes).
  • FDA biocompatibility requirements.
  • ASTM D 5712-95 (for residual protein level).

8. The Sample Size for the Training Set:

• N/A. As this is a physical product and not an AI/machine learning device, there is no "training set."

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

• N/A. No training set is applicable to this product.

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A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

This document describes the acceptance criteria and performance data for ROYAL SHIELD PINK COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT STRAWBERRY SCENTING & A PROTEIN LABELLING CLAIM.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance Claim: The data presented indicate that the Royal Shield Powdered latex examination glove:

1. meets/exceeds ASTM-D3578-99 Standard Specifications For Latex Examination Glove.
2. meets FDA pinhole requirements.
3. meets the protein labeling claim level at <200 µg/g.

This document does not describe a study involving an AI device or human readers. It pertains to the conformance of latex examination gloves to established medical device standards. Therefore, sections 2-6 and 8-9 are not applicable in their entirety as framed for an AI device study. However, I will map the intent of these questions to the available information.

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

• Water Tight Test:
  • Batch 9009-9037 XS: 200 gloves
  • Batch 9019-9023 S: 315 gloves
  • Batch 9030-9039 M: 200 gloves
• Tensile Strength & Ultimate Elongation: The sample size for these tests is not explicitly stated in the provided text, but data is reported for multiple tests (e.g., "20 May 99").
• Biocompatibility: Sample sizes for the primary dermal irritation and skin sensitization studies are not explicitly stated.
• Residual Protein Level: Sample size is not specified.
• Data Provenance: The document is a 510(k) summary submitted to the FDA in the United States. The manufacturer is "Shield Gloves Manufacturer (M) Sdn. Bhd." which suggests the company is likely based in Malaysia (Sdn. Bhd. is a common abbreviation for private limited companies in Malaysia). The tests were conducted on specific dates (e.g., "20 May 99", "19 May 99"). This would be considered prospective testing for the purpose of demonstrating compliance for the 510(k) submission.

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

• This question is not applicable. The "ground truth" for glove performance is defined by established international standards (ASTM-D3578-99, ASTM D 5712-95) and FDA biocompatibility requirements, not by expert consensus on individual cases. The measurements are objective physical and chemical tests.

4. Adjudication Method for the Test Set

• This question is not applicable. Performance is determined by objective measurements against predefined criteria/standards, not by human interpretation or adjudication in the context of diagnostic performance.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This document is for examination gloves, which are physical barriers, not diagnostic tools.

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

• No, a standalone algorithm performance study was not done. This is not an AI device. The tests performed are for the physical, chemical, and biological properties of the gloves.

7. The Type of Ground Truth Used

• The "ground truth" is defined by established international standards (ASTM-D3578-99, ASTM D 5712-95), FDA pinhole requirements, and FDA biocompatibility requirements. These standards specify acceptable ranges for physical properties (dimensions, tensile strength, elongation), acceptable quality levels (AQL) for watertightness (pinholes), and qualitative outcomes for biological reactions (irritation, sensitization).

8. The Sample Size for the Training Set

• This question is not applicable as this is not an AI device that requires a training set. The "training" for a manufacturing process is implicit in quality control and process validation, which are not detailed here in terms of sample sizes for "training data."

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

• This question is not applicable as this is not an AI device. The manufacturing process of gloves is governed by established engineering and quality control principles, not by a "training set" with ground truth in the AI sense.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and the study that proves the device, SMART SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT, meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

For the water-tightness test, the sample size used was 200 pieces for each glove size (Small, Medium, M-Large, Large). This suggests a total of 800 gloves were tested for water tightness.
The data provenance is from the manufacturer's internal testing (Shield Gloves Mfr's), conducted to meet FDA and ASTM standards. The specific country of origin is Malaysia (Shield Gloves Manufacturer (M) Sdn. Bhd.). The data appears to be prospective as it involves direct testing of manufactured batches.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any of the tests. The tests performed (dimension, physical properties, water leak, biocompatibility, residual powder) are objective measurements against established ASTM and FDA standards, not subjective expert assessments.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests rely on objective measurements and pass/fail criteria against predefined standards (ASTM, FDA). There is no indication of a need for expert adjudication for these specific performance metrics.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of results (e.g., radiology images) to assess the impact of AI on human reader performance. For examination gloves, the performance metrics are largely objective and physical.

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

Yes, the studies described are all standalone performance evaluations of the glove itself. There is no algorithm or human-in-the-loop component relevant to the testing presented. The device is a physical product, not an AI or software-as-a-medical-device.

7. The Type of Ground Truth Used

The ground truth for all evaluated parameters were established standards and specifications:

• ASTM D3578-95 and ASTM DRAFT NITRILE for dimensions, tensile strength, and ultimate elongation.
• FDA specified 1,000 ml water leak test and ASTM D 5151-90 for water tightness.
• FDA biocompatibility requirements for primary dermal irritation and skin sensitization.
• FDA internal requirements (not exceeding 2 mg/glove) for residual powder content, measured by ASTM D 6124.
• Negative Iodine test for cornstarch presence.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical product (nitrile gloves) and not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical medical glove.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

This document describes the acceptance criteria and supporting studies for the ROYAL SHIELD POWDER FREE LATEX EXAMINATION GLOVES WITH BUBBLE GUM SCENT AND PROTEIN CONTENT LABELING.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Water Tight Test: 200 gloves per size (X-Small, Small, Medium, Large), for a total of 800 gloves. The provenance of this data is not explicitly stated (e.g., country of origin, retrospective/prospective). It is presented as internal test results for "SHIELD's" product.
• Other Physical Properties (Dimension, Tensile Strength, Elongation): The sample sizes are not explicitly stated for these tests beyond the reported direct performance values for "SHIELD's".
• Biocompatibility: The specific sample sizes for the Primary Dermal Irritation Test and Skin Sensitization Study are not provided, only the "RESULTS."
• Residual Powder Content & Presence of Cornstarch: The specific sample size for these tests is not explicitly stated beyond "Range: 1.5-1.9mg/glove Mean : 1.7 mg/glove".
• Residual Protein Level: Same as above, not explicitly stated beyond "Range: 27-33 Mean: 30".

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

Not applicable. This document pertains to the physical and chemical testing of a medical device (examination gloves), not to a study requiring expert interpretation or ground truth establishment in a diagnostic or clinical context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This document describes the performance characteristics of an examination glove against established physical, chemical, and biological standards, not the comparative effectiveness of a diagnostic tool or a treatment with human readers.

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

Not applicable. This document is about a physical medical device (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests are established industry standards and regulatory requirements, specifically:

• ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application: This standard defines the physical properties (dimensions, tensile strength, ultimate elongation) that the gloves must meet.
• FDA specified 1,000 ml water leak test / FDA/ASTM requirements for latex exam gloves of 4.0% AQL: This defines the leakage acceptance rate.
• FDA biocompatibility requirements: These are the benchmarks for the dermal irritation and sensitization tests.
• FDA INTERNAL REQUIREMENT (2 mg/glove max) for Residual Powder Content (per ASTM D 6124-97): This specifies the maximum allowable powder.
• FDA ALLOWABLE LEVEL (< 50 µg/g) for Residual Protein Level (per ASTM D 5712-95): This sets the maximum allowable protein.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no training set.

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

Not applicable. There is no training set for this device.

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A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance of "ROYAL SHIELD POWDER FREE GREEN LATEX EXAM GLOVES." This is a Class I medical device (examination gloves), and the study conducted focuses on demonstrating its physical and chemical properties meet established standards, rather than evaluating an AI-powered diagnostic or therapeutic device. Therefore, many of the requested elements pertaining to AI studies (like MRMC, ground truth establishment for AI, expert qualifications, adjudication methods, training/test set sizes for AI algorithms) are not applicable to this type of device and study.

Here's a breakdown of the acceptance criteria and reported device performance based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a medical glove)

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

   • Water Tight Test: 200 pieces for each size (X-Small, Small, Medium, Large) were tested. This totals 800 gloves across four batches.
   • Dimension, Physical Properties, Biocompatibility, Residual Powder, Presence of Cornstarch, Residual Protein Level: Sample sizes for these tests are not explicitly stated, but the "reported device performance" implies sufficient samples were tested to generate ranges and means for these characteristics.
   • Data Provenance: The data comes from the manufacturer, Shield Gloves Manufacturer (M) Sdn. Bhd., as part of their 510(k) submission to the FDA. The location implies an origin outside the US (Sdn. Bhd. is a Malaysian company designation). It is prospective in the sense that these tests were conducted on the manufactured product to demonstrate compliance.

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

   • Not applicable as this is not a study assessing diagnostic performance by human experts. The "ground truth" for glove performance refers to meeting established physical and chemical standards as defined by ASTM and FDA requirements.

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

   • Not applicable. Performance is measured against objective standards and laboratory 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 device or an imaging diagnostic system.

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

   • Not applicable. This is not an AI device. The device itself (the glove) is being tested in a standalone manner against physical/chemical criteria.

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

   • The "ground truth" refers to established industry standards and regulatory requirements. This includes:
     • ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application for dimensions and physical properties.
     • FDA specified 1,000 ml water leak test and 4.0% AQL.
     • FDA biocompatibility requirements.
     • ASTM D 6124-97 for Residual Powder Content.
     • ASTM D 5712-95 for Residual Protein Level.

7. The sample size for the training set:

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

8. 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 hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

I am sorry. I cannot fulfill this request. The provided text describes the safety and effectiveness of latex examination gloves, which is a medical device, but it lacks the specific information required to address your questions about acceptance criteria for an AI/ML powered medical device. The text does not mention any AI or machine learning components, nor does it detail studies involving human readers or ground truth established by experts in the context of AI.

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