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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.

This document is a 510(k) clearance letter for medical examination gloves. It is not a document describing a study for a medical device that uses AI or requires expert ground truth. Therefore, I cannot provide the requested information.

The prompt specifically asks for details related to:

• A table of acceptance criteria and device performance for an AI/ML device.
• Sample sizes for test and training sets (relevant to AI/ML).
• Number and qualifications of experts for ground truth (relevant to AI/ML).
• Adjudication methods (relevant to AI/ML).
• MRMC studies (relevant to AI/ML).
• Standalone algorithm performance (relevant to AI/ML).
• Type of ground truth used (relevant to AI/ML).
• How ground truth was established for training (relevant to AI/ML).

The provided text discusses the non-clinical performance testing of rubber examination gloves. The "acceptance criteria" and "results" tables in the document pertain to physical and chemical properties of gloves (e.g., length, width, thickness, tensile strength, protein content, biocompatibility) tested against established ASTM and ISO standards for medical gloves.

There is no mention of an algorithm, AI, machine learning, human-in-the-loop performance, or expert review for diagnostic purposes. The "ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established industry standards, not expert interpretations of medical images or data.

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The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.

The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves Biodegradable (Green). It describes the device, its intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document pertains to a medical device (examination gloves) that is a physical product, not an AI/software-based device. Therefore, several of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable in this context, as they relate specifically to the validation of AI/ML systems or diagnostic aids, not physical medical devices like gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves and biocompatibility.

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

The document does not explicitly state the numerical sample size for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests are conducted according to recognized standards (ASTM, ISO), which inherently specify sampling plans and test methods (e.g., AQL 1.5 for hole detection typically implies a specific sampling size based on lot size).

• Data Provenance: The tests were conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The data appears to be prospective as it directly supports the 510(k) submission for this specific device.

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

Not Applicable. For a physical product like medical gloves, "ground truth" is established through standardized physical, chemical, and biological testing methods (e.g., measuring dimensions, tensile strength, or observing biological reactions in animal models), not through expert consensus on interpretations like with AI/imaging data. The standards themselves define the "ground truth" for compliance.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for subjective human assessments, particularly in image interpretation or clinical diagnosis. For physical and chemical property testing of gloves, the results are typically objective measurements or observations by trained laboratory personnel following the specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

Not Applicable. MRMC studies are used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing human reader performance with and without the system. This is not relevant for a physical product like examination gloves.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not Applicable. "Standalone" performance refers to the diagnostic capability of an algorithm or AI without human interaction. This concept does not apply to a physical medical device. The device's performance is intrinsically linked to its physical and material properties.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements and observations derived from:

• Standardized Test Methods: Adherence to established and recognized international standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D5511-18, ASTM D6124-06(2022), ISO 10993 series). These standards define the test procedures and acceptance criteria for various physical, chemical, and biological properties.
• Direct Physical and Chemical Analysis: Measurements of dimensions, tensile strength, elongation, residual powder, and observations of biodegradation and biocompatibility reactions.
• Biological Endpoints: For biocompatibility, the ground truth is based on the observed biological response (e.g., presence/absence of irritation, sensitization, or systemic toxicity) in established animal or in-vitro models as per ISO 10993.

8. The Sample Size for the Training Set

Not Applicable. The concept of a "training set" (for machine learning models) does not apply to the development or validation of a physical medical device like these gloves. The manufacturing process is controlled by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation), and product performance is validated through testing of manufactured lots against specifications, not through machine learning.

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

Not Applicable. As mentioned above, there is no "training set" in the context of this device. The physical and performance characteristics are inherent to the material and manufacturing process, validated through testing against pre-defined standards.

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The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document pertains to the 510(k) submission for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528).

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

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

• Physical Dimensions, Physical Properties, Powder Residue, Freedom from Holes: The specific sample sizes are not explicitly stated within the provided text, but the tests were conducted according to ASTM and ISO standards (e.g., ISO 2859-1/S2/AQL 4.0 for dimensions, AQL 1.5 for freedom from holes), which prescribe sampling plans. The data provenance is from non-clinical tests conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd. No country of origin for the specific testing labs is provided, nor is it specified if the data is retrospective or prospective, though it's likely prospective for the submission.
• Irritation, Sensitization, Cytotoxicity, Acute systemic toxicity: The specific sample sizes for these biocompatibility tests are not explicitly stated in the document. These tests are likely performed ex vivo or in vivo with animal models (e.g., mice for acute systemic toxicity) or in vitro (e.g., for cytotoxicity). The data provenance is from non-clinical tests conducted by the manufacturer.
• Low Dermatitis Potential (Modified Draize): The specific sample size for the human repeat insult patch test (HRIPT) is not explicitly stated. The Modified Draize test (ASTM 6355-07) is a clinical test involving human subjects, therefore, the data provenance is clinical, likely from a prospective study.

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

This information is not provided in the document. The tests performed are primarily laboratory-based or standardized clinical tests with defined acceptance criteria, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or complex diagnostic tasks. The "ground truth" for these tests is the quantitative or qualitative outcome against a standard.

4. Adjudication method for the test set:

Not applicable. The tests performed are objective, standardized tests with predefined acceptance criteria. There is no mention or implication of a need for adjudication by multiple human experts for the results of these physical, chemical, or biological tests.

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 a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to this submission.

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

Not applicable. This device is a medical glove, not an algorithm or software.

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

The ground truth for most of these tests is based on objective measurements and established standards:

• Physical Properties (Dimensions, Tensile Strength, Elongation, Powder Residue, Freedom from Holes): Ground truth is based on quantitative measurements against the physical requirements specified in ASTM D6319-19, ASTM D412-16(2021), ASTM D6124-06(2022), and ASTM D5151-19.
• Biocompatibility (Irritation, Sensitization, Acute Systemic Toxicity): Ground truth is based on observations and measurements from standardized biological evaluations (ISO 10993 series) against set criteria for biological responses.
• Cytotoxicity: Ground truth is based on observable cellular responses in in vitro tests (ISO 10993-5).
• Low Dermatitis Potential (Modified Draize): Ground truth is based on the absence of clinical evidence of Type IV allergy in human subjects, as observed and reported in the HRIPT study, following ASTM 6355-07. This involves clinical observation in human subjects.

8. The sample size for the training set:

Not applicable. This is a physical medical device (gloves) and not an AI/ML-based algorithm that requires a training set.

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

Not applicable. As this device is a medical glove, it does not involve a training set or associated ground truth establishment for an AI/ML model.

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The Blue Colored, Powder Free Nittrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a patient medical exam glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319 -10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

This document pertains to the 510(k) premarket notification for "Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K192954). The information provided is primarily focused on the non-clinical performance data of these gloves, specifically their resistance to permeation by chemotherapy drugs and fentanyl citrate, as well as their general physical properties and biocompatibility.

The request asks for information relevant to the acceptance criteria and study proving a device meets acceptance criteria, typically in the context of an AI/ML medical device. The provided document is for a physical medical device (examination gloves) and not an AI/ML-driven device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.

However, I can extract the relevant information regarding acceptance criteria and how the performance of these gloves was evaluated based on the provided text.

Acceptance Criteria and Device Performance (for Nitrile Examination Gloves)

The device performance was evaluated against established industry standards for examination gloves. The primary performance criteria highlighted are related to the permeation of chemotherapy drugs and fentanyl citrate, as well as general physical characteristics and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., number of gloves tested for permeation, water leak, or biocompatibility). The results are presented as "Pass" or average breakthrough times, which implies testing was conducted on a sufficient number of samples according to the respective ASTM/ISO standards.
• Data Provenance: The device manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., is located in Matang, Perak, Malaysia. The tests were conducted according to international standards (ASTM, ISO), but the specific laboratory location is not detailed. The data is non-clinical performance data, generated from laboratory testing, not human patient data (retrospective/prospective healthcare records).

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

• This question is not applicable as the document describes a physical medical device (gloves) and their material/chemical resistance testing, not an AI/ML algorithm requiring expert ground truth for interpretation of medical images or data. Performance is determined by established engineering and chemical testing standards.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as above. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert consensus for AI/ML performance evaluation, not for laboratory testing of a physical product's material properties.

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 question is not applicable as this submission is for a physical medical device (gloves) and not an AI/ML-driven device or an AI-assisted human reader study.

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

• This question is not applicable as this is not an algorithm or AI-driven device. The "standalone" performance refers to the intrinsic properties of the glove material against chemical permeation and physical stress.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by well-defined, internationally recognized laboratory testing standards and methods (e.g., ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151 for water leak, ISO 10993 for biocompatibility). These standards specify the experimental procedures and often the criteria for "pass" or "fail" for the material properties of the gloves. The "truth" is based on the physical and chemical behavior observed under these controlled experimental conditions.

8. The Sample Size for the Training Set

• This question is not applicable as this is not an AI/ML device. There is no "training set" in the context of device performance, but rather test samples used for validation against defined standards.

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

• This question is not applicable for the same reason as above.

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The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these qloves are worn to protect the wearer aqainst exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows:
Cisplatin 1.0 mg/ml >= 240
Cyclophosphamide (Cytoxan) 20 mg/ml >= 240
Dacarbazine (DTIC) 10.0 mg/ml >= 240
Doxorubicin Hydrochloride 2.0 mg/ml >= 240
Etoposide (Toposar) 20.0 mg/ml >= 240
Fluorouracil 50.0 mg/ml >= 240
Paclitaxel (Taxol) 6.0 mg/ml >= 240
*Carmustine (BCNU) 3.3mg.ml 54.1 (minutes)
*Thiotepa 10.0 mg/ml 6.0 (minutes)
*Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa.
Tested Fentanyl Citrate is as follows: Fentanyl Citrate Injection 100.0 mcg/2ml Average Breakthrough Detection Time (minutes) >= 240

Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets the requirements of ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

This document describes the premarket notification (510(k)) for Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. This is a medical device, and the acceptance criteria and study proving it meets these criteria are based on non-clinical performance standards rather than an AI/human reader study.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are generally defined by adherence to specific ASTM and ISO standards for examination gloves. The reported device performance is presented in several tables.

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

• Sample Sizes:
  • Physical Property Tests (Tensile Strength, Elongation): 13 samples (Table 4, Table 5)
  • Freedom From Holes: 80 samples/batch (Table 5)
  • Powder Residual Test: 1 sample (Table 6)
  • Chemotherapy and Fentanyl Permeation Tests: 3 specimens per drug (e.g., Specimen 1/2/3 in Table 7 and 8)
  • Quality Assurance Testing: Batch inspection levels (S-2 for Dimension/Tensile, G-1 for Water Leak). The AQL (Acceptable Quality Level) values (4.0 or 1.5) and inspection levels indicate a sampling plan from production lots, not a fixed pre-defined test set.
• Data Provenance: The document does not explicitly state the country of origin of the test data or whether the studies were retrospective or prospective. Given the submitter (Comfort Rubber Gloves Industries Sdn. Bhd.) is located in Malaysia, it is highly probable that the testing was conducted in Malaysia or a recognized testing facility accessible to them. The tests are non-clinical (laboratory/material tests), so the "prospective/retrospective" distinction isn't typically applied as it would be for a clinical study with human subjects.

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 device is a physical medical glove and the acceptance criteria are based on objective, quantifiable physical and chemical properties measured according to established international standards (ASTM, ISO, FDA methods). Therefore, the "ground truth" is established by these laboratory tests and their measurement results, not by expert consensus or interpretation as would be the case for diagnostic imaging AI. No interpretation by medical experts (like radiologists) is relevant for establishing the "ground truth" for glove performance.

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

Not applicable. This device is not an AI/diagnostic device that relies on human interpretation or adjudication for its "ground truth." The tests are laboratory-based with objective metrics.

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 physical medical device (examination gloves), not a diagnostic AI system or an imaging device. Therefore, MRMC studies are not relevant to its evaluation.

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. The performance evaluation is solely based on its physical and chemical properties as measured in a lab, which is "standalone" in the sense that no human-in-the-loop interaction is required for the device's function or evaluation.

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

The "ground truth" for this device's performance is established through:

• Adherence to Established Standards: ASTM (American Society for Testing and Materials) standards for physical properties of medical gloves (e.g., D6319 for dimensions, tensile strength, elongation; D6124 for powder residue; D5151 for holes), and D6978 for chemotherapy drug permeation.
• International Organization for Standardization (ISO) Standards: ISO 10993 for biocompatibility (irritation, sensitization, cytotoxicity).
• FDA Test Methods: Specifically, the FDA 1000ml water leak test method (21 CFR 800.20).
• Objective Laboratory Measurements: The numerical results from these tests (e.g., tensile strength in MPa, elongation in %, breakthrough detection time in minutes, powder content in mg/glove).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "device" itself is manufactured and tested according to engineering and material science principles.

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

Not applicable, as no training set exists for this type of device.

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The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

This document is a 510(k) premarket notification for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black). It describes the device and compares it to a predicate device (Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green), K180476).

Since this document is for a medical glove, not an AI/ML powered medical device, the information requested in the prompt related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable. The device's performance is demonstrated through non-clinical testing against recognized standards.

Here's a breakdown of the acceptance criteria and performance as gathered from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device, "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)," meets established standards for medical examination gloves. The key acceptance criteria and reported performance, especially concerning chemotherapy drug permeation, are detailed below. The comparison is made against the predicate device (K180476) and relevant ASTM/ISO standards.

Study Information for the Device:

As mentioned, much of the requested information is for AI/ML devices and is not applicable to a physical medical device like examination gloves. The provided document is a 510(k) submission, confirming substantial equivalence to a predicate device based on non-clinical performance testing.

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 for Test Set: Not explicitly stated but implied to be sufficient for compliance with the referenced ASTM and ISO standards for glove testing (e.g., ASTM D6978 for chemotherapy permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility). These standards define sampling plans for lot release testing. For instance, ISO 2859 for "Sampling Procedures and Tables for Inspection by Attributes" is referenced, indicating a statistical sampling approach.
• Data Provenance: The manufacturing company is Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The testing would presumably have been conducted in laboratories, potentially in Malaysia or certified testing facilities elsewhere, in accordance with the specified international standards. The data is prospective in the sense that the tests 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 (e.g. radiologist with 10 years of experience)

• Not applicable. The "ground truth" for a medical glove is determined by its physical and chemical properties as measured against established performance standards, not by expert interpretation of data. Laboratory testing provides the objective "ground truth."

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, typically in clinical readings or image analysis for AI/ML. For glove testing, objective measurements are taken according to standard protocols.

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 physical medical device, not an AI-powered diagnostic tool.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" is established through objective laboratory testing results against predetermined pass/fail criteria defined by international standards (ASTM, ISO). These tests measure properties such as physical dimensions, tensile strength, elongation, powder content, integrity (watertightness), chemotherapy drug permeation time, skin irritation, sensitization, and cytotoxicity.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

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 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:

Please note that the following drugs have extremely low permeation time for
*Carmustine (BCNU) 3.3mg.ml - 23.4 (mins)
*Thiotepa 10.0 mg/ml - 16.2 (mins)

The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green). The proposed device is for single use and is provided non-sterile. The device meets the requirements for dimensions, physical properties, and thickness in ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application. The device accomplishes its intended function by creating a physical barrier between the examiner and patient and creates a barrier for the chemotherapy drugs listed in the Indications for Use.

This document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves tested for use with chemotherapy drugs. It focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Here's the information extracted and organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the chemotherapy drug permeation test appears to be established by comparison to the predicate devices. For most drugs, the criterion is a minimum breakthrough detection time of ">240 minutes". For Carmustine and Thiotepa, the low permeation times observed for both the new device and the predicate lead to a warning statement, indicating that these drugs have "extremely low permeation times" and are not held to the ">240 minutes" criterion.

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

• The document does not explicitly state the sample size used for the test set for properties like chemotherapy drug permeation, physical properties, or biocompatibility. It only reports "meets" or specific breakthrough times, implying that tests were conducted according to relevant standards (e.g., ASTM D6978-05 for chemotherapy drug permeation and ASTM D6319-10(2015) for physical properties and dimensions). These standards typically define sampling plans.
• Data Provenance: The manufacturer is Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The document does not specify if the testing was performed in Malaysia or another country. The data is non-clinical performance data, likely from prospective testing conducted to support 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 information is not applicable as the device is a medical glove, and its performance is evaluated through objective, standardized laboratory tests against established physical, chemical, and biological criteria, not through expert interpretation of images or patient data to establish a ground truth.

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

• This is not applicable. The evaluation of medical gloves against performance standards (e.g., ASTM, ISO) involves quantitative measurements and predefined pass/fail criteria, not subjective interpretation requiring adjudication by experts.

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 is not applicable. The device is a physical medical glove, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

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

• This is not applicable. The device is a physical medical glove and does not involve any algorithm or AI component.

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

• The "ground truth" for this device is based on objective, standardized test methods and criteria defined by international and national standards (e.g., ASTM D6319, ASTM D6124, ASTM D6978, ISO 10993, 21 CFR 800.20). These standards establish the acceptable performance characteristics for medical gloves. For biocompatibility, it's based on "passes" criteria of ISO standards. For chemotherapy permeation, it's the objectively measured breakthrough detection time.

8. The sample size for the training set:

• This is not applicable. The device is a physical medical glove and does not utilize a "training set" in the context of machine learning or AI. Its design and manufacturing are based on engineering principles and material science, not data-driven model training.

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

• This is not applicable for the reasons stated in point 8.

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The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) summary for "Powder Free Nitrile Examination Gloves (Orange)". This document outlines the device's characteristics and compares them to a predicate device to establish substantial equivalence, which is a regulatory pathway for medical devices. It does not describe a clinical study in the typical sense of evaluating the effectiveness or safety of a new medical treatment or diagnostic algorithm.

Instead, the document details non-clinical performance data to demonstrate that the new device (Powder Free Nitrile Examination Gloves (Orange)) meets established standards and performs similarly to a legally marketed predicate device (Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, K140418).

Here's an analysis of the requested information based on 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)

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, physical properties, or watertightness). However, the tests are performed according to recognized standards (ASTM, ISO, CFR), which typically specify appropriate sampling plans.

• Data Provenance: The manufacturer is "Comfort Rubber Gloves Industries Sdn. Bhd." located in Matang, Perak, Malaysia. The testing would have been conducted by or for this manufacturer. The data is prospective in the sense that these tests are performed on the manufactured product to ensure it meets the specified standards.

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 to this type of device and study. The "ground truth" here is objective physical and chemical properties measured against established industry standards (ASTM, ISO, CFR). It does not involve expert interpretation or clinical judgment.

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

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The tests involve objective measurements and pass/fail criteria based on 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

Not applicable. This is a 510(k) submission for examination gloves, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI integration, or assessment of human reader improvement is relevant or performed.

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 AI system.

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

The "ground truth" for the non-clinical tests are established, objective performance standards and specifications documented in:

• ASTM D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D6124-06 (2011) - Standard Test Method for Residual Powder on Medical Gloves
• ISO 10993-10:2010 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
• 21 CFR 800.20 - Medical device general controls
• ASTM D5151 - Standard Test Method for Detection of Pinholes in Medical Gloves by Visual Inspection of the Inflated Glove

These standards define the acceptable range or threshold for physical properties (length, tensile strength, elongation, thickness), chemical properties (powder content), biological reactions (biocompatibility), and integrity (watertightness).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. The gloves are manufactured and then tested against established standards.

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

Not applicable for the same reason as point 8. The standards themselves are developed through industry consensus, scientific research, and regulatory requirements, not through a "training set" for an algorithm.

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The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.

The proposed devices are Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim. The gloves are available in two colors: blue and white. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)" and "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)". This document is for a medical device (gloves) and not for an AI/ML-driven medical device or software. Therefore, the questions related to AI/ML device testing (such as sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the content provided.

However, I can extract the acceptance criteria and the study results for the glove's performance as presented in the document, especially regarding its resistance to chemotherapy drugs and other physical properties.

Here's the information based on the provided document, addressing the relevant points and indicating "N/A" for those that do not apply to this type of device:

Device Description: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are primarily based on ASTM standards and comparisons to a predicate device (K141982). The key performance characteristic tested for this submission is the "Breakthrough Detection Time" for various chemotherapy drugs, which reflects the glove's ability to protect against exposure.

Acceptance Criteria & Device Performance Comparison (Current Device vs. Standards/Predicate)

Note: For Carmustine and Thiotepa, while the breakthrough times might seem low, the predicate also had low times (Thiotepa as low as 2 minutes). The current device shows improved or comparable performance for these challenging drugs, and the critical acceptance criterion is that the warning statement regarding these drugs' properties is present and updated to reflect the tested performance.

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

The document does not specify the exact sample size for each specific test (e.g., number of gloves tested for chemotherapy permeation or physical properties). However, the testing would have been conducted in accordance with the cited ASTM standards, which define the necessary sample sizes and testing methodologies for such evaluations.

• Data Provenance: The device is manufactured by Comfort Rubber Gloves Industries Sdn Bhd in Matang, Perak, Malaysia. The testing data would originate from laboratory tests conducted on the manufactured gloves.
• Retrospective or Prospective: These tests are prospective (pre-market) evaluations conducted specifically to support the 510(k) submission.

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

N/A. This is a physical device where "ground truth" is established through standardized laboratory testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility) that yield objective measurements, rather than expert interpretation of complex data (like medical images).

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

N/A. Not applicable for physical device performance testing.

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

N/A. Not applicable for this physical device.

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

N/A. Not applicable for this physical device.

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

The "ground truth" for this device is based on objective measurements derived from standardized laboratory test methods (e.g., ASTM standards for glove performance and ISO standards for biocompatibility). For instance, the breakthrough detection time for chemotherapy drugs is a direct measurement based on chemical analysis, not expert consensus or clinical outcomes.

8. The sample size for the training set

N/A. This document pertains to a physical medical device (gloves), not an AI/ML system requiring a training set.

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

N/A. This document pertains to a physical medical device (gloves), not an AI/ML system.

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A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or finger(s) to prevent contamination between patient and examiner.

POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES

This document is a 510(k) clearance letter from the FDA for Powder-Free Nitrile (Black) Examination Gloves. It does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device or AI system.

The text explains that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include any performance data or study details typically found in a summary of safety and effectiveness.

Therefore, I cannot fulfill your request for the specific information.

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