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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.

• Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.

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

This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.

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 typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.

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

Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
• Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
• Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
• Freedom from holes is evaluated by ASTM D5151-19.
• Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).

8. The Sample Size for the Training Set:

This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.

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

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

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The 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.

The glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023).

The subject device is single use, disposable and non-sterile gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded cuff, Blue/Black colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in six sizes: XS, S, M, L, XL, XXL.

This FDA 510(k) summary describes the acceptance criteria and the study results for the Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for the test sets for each specific test (e.g., how many gloves were tested for length, how many for water leak). However, the standard ASTM D6319-19(2023) and other listed standards would define the required sample sizes for each test to ensure statistical validity.

The data provenance is not explicitly stated in terms of country of origin of the data or retrospective/prospective. However, the tests are "non-clinical tests" conducted to verify design specifications and conform to international and national standards (ASTM, ISO). This suggests the data was generated through controlled laboratory testing following these specified methodologies.

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

This device is a medical glove, and its performance evaluation primarily relies on objective, standardized laboratory tests against defined physical, chemical, and biological endpoints, not subjective expert assessment of images or clinical cases. Therefore, the concept of "experts establishing ground truth for a test set" as typically understood in AI/imaging studies does not apply here. The "ground truth" for these tests is the quantitative measurement results compared to the established thresholds defined by the standards.

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

Not applicable. As mentioned above, the evaluation relies on objective analytical tests rather than subjective human assessment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for the performance evaluation of these gloves is based on objective measurements and chemical analysis as defined by the referenced ASTM and ISO standards. For example:

• Physical properties (length, width, thickness, tensile strength, elongation): Measured values compared to a numerical range or minimum defined by ASTM D6319.
• Freedom from holes (water leak test): Objective criteria (AQL 2.5) for defect detection.
• Powder residue: Quantitative measurement (Max 2mg/glove).
• Chemical permeation (chemotherapy drugs and Fentanyl Citrate): Directly measured breakthrough detection time (BDT) in minutes, as per ASTM D6978.
• Biocompatibility (Sensitization, Irritation, Cytotoxicity, Systemic Toxicity): Laboratory test results demonstrating lack of adverse biological reactions as defined by ISO 10993 standards and evaluated against established pass/fail criteria (e.g., no evidence of sensitization, no irritancy, no mortality/toxicity).

8. The sample size for the training set:

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

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

Not applicable. This is not an AI/machine learning device.

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A Nitrile powder free examination glove is a disposable device intended purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with 46 Chemotherapy drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate.

Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)

This document is an FDA 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)". This is a Class I medical device (non-powdered patient examination glove).

The document does not describe an AI/ML-driven medical device, nor does it contain information about clinical study results, expert adjudication, or ground truth establishment relevant to AI/ML device performance. It is a regulatory clearance letter for a physical product (gloves) and lists testing results for breakthrough times against various chemicals for the purpose of demonstrating the device's protective capabilities.

Therefore, the requested information cannot be extracted from the provided text. The questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable to the content of this document.

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The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.

The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.

There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.

The materials and the manufacturing process technology are the same.

The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for a test set or data provenance for an AI/ML device.
3. Number of experts used to establish ground truth or their qualifications for an AI/ML device.
4. Adjudication method for an AI/ML device test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
8. Sample size for the training set of an AI/ML device.
9. How the ground truth for an AI/ML training set was established.

However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.

Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves

This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing of Gloves):

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

• The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
• Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."

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

• This is not applicable as the device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.

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

• Not applicable for this type of device 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:

• 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:

• For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
• For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
• For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.

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

• Not applicable as this is not an AI/ML device.

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Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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.

Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTMD6978- 05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided text describes the acceptance criteria and performance data for a medical device: "Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study of an AI algorithm. Therefore, many of the requested points related to AI/algorithm performance are not applicable.

Here's the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are primarily based on established ASTM and ISO standards for medical gloves.

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves for physical dimensions, number of test replicates for permeation). However, the standard ASTM D6319-19 for physical dimensions and freedom from holes, and ASTM D6978-05 for permeation, typically define the sampling plans.

The data provenance is from "Yue Kang Anhui Medical Products Co., Ltd" in China. The studies are non-clinical performance tests, conducted to verify the device meets design specifications and relevant standards. They are retrospective in the sense that they are tests performed on manufactured products, not prospective clinical trials.

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

Not applicable. This document is for a medical glove, and the "ground truth" for the test set is established by the specifications of industrial standards (ASTM, ISO) and laboratory testing methodologies, not by expert medical review or consensus on images/data.

4. Adjudication Method for the Test Set

Not applicable. As described above, the compliance is determined by adherence to standardized test methods and their defined acceptance criteria. There is no human adjudication process involved in these performance tests.

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

Not applicable. This is a submission for a physical medical device (glove) and does not involve an AI algorithm or human-in-the-loop performance evaluation.

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

Not applicable. This submission is for a medical glove, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is defined by the technical specifications and performance requirements outlined in the referenced industry standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D412-16, ASTM D6978-05, ISO 10993-10, ISO 10993-23, ISO 10993-11). These standards represent established, objective, and reproducible test methods for evaluating medical glove performance and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model, 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 type of device.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.

The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):

Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).

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

• The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
• Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.

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 physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.

4. Adjudication method for the test set:

• This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is not applicable. This device is an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

• This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.

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 against established performance standards and chemical permeation resistance thresholds.
  • For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
  • For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
  • For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.

8. The sample size for the training set:

• This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.

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

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

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Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.

In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl, and Gastric Acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I) and come in eight sizes (XXS, XS, S, M, L, XL, and XXL). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves and Modified Draize Test. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, fentanyl, and Gastric Acid.

The provided document is a 510(k) Premarket Notification for a medical device: "Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid."

The document details the technical characteristics and performance of the device through various tests, often comparing it to predicate devices. It describes the acceptance criteria and study results primarily for the physical and chemical resistance properties of the gloves, as well as biocompatibility testing.

However, it's crucial to note that this document DOES NOT describe a study involving an AI or algorithm-driven device (e.g., for image analysis or disease detection). Therefore, many of the specific questions about human readers, AI assistance, ground truth establishment for AI training, and expert adjudication are not applicable to this type of device and study.

The study described is a non-clinical performance and chemical permeation study of a physical medical device (gloves), not an AI/ML-driven diagnostic or therapeutic system.

Given this, I will describe the acceptance criteria and the study that proves the device meets them based only on the information available in the provided document, acknowledging the non-applicability of AI/ML-specific questions.

Acceptance Criteria and Device Performance for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (K233560)

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed against recognized ASTM and ISO standards for medical gloves, primarily focusing on physical properties, freedom from defects, biocompatibility, and resistance to chemical permeation.

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

• Physical and Chemical Resistance Tests: The document does not specify the exact sample sizes for each physical or chemical permeation test. However, these tests are generally performed on a sufficient number of glove samples to meet the requirements of the specified ASTM standards (e.g., ASTM D5151 for pinholes usually involves a large number of gloves for AQL testing).
• Biocompatibility / Modified Draize-95 Test (Low Dermatitis Potential Claim):
  • Sample Size: 211 subjects initially recruited, with 205 subjects completing the two stages of the study (6 subjects discontinued due to poor compliance).
  • Data Provenance: Not explicitly stated (e.g., country of origin), but the study was performed to support a 510(k) submission to the FDA for sale in the US market. Given the manufacturer is based in Malaysia (Eco Medi Glove Sdn. Bhd.), it is plausible the study was conducted there or in a region with compatible regulatory standards.
  • Retrospective or Prospective: This was a prospective clinical study (Modified Draize-95 Test) specifically conducted to evaluate the low dermatitis potential of the device.

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

• For physical and chemical resistance tests: Ground truth is established by objective, standardized laboratory measurements based on ASTM and ISO methods. No human "experts" in the sense of adjudicating medical images or clinical outcomes are involved in establishing ground truth for these types of tests.
• For the Modified Draize-95 Test: The ground truth for skin sensitization (type IV allergy) or irritation is based on the clinical observation of the subjects' skin reactions by qualified personnel (e.g., dermatologists or trained clinical researchers) following the specified protocol (FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products" (1999) which pertains to the Modified Draize-95 Test). The document does not specify the number or specific qualifications of these observers, but it is implied they are clinical professionals capable of evaluating skin reactions.

4. Adjudication Method for the Test Set

• For physical and chemical resistance tests: No adjudication is typically needed as tests are objective measurements against defined thresholds.
• For the Modified Draize-95 Test: The nature of the Modified Draize test involves direct clinical observation for skin reactions. While not explicitly stated as "adjudication," the interpretation of skin reactions by the clinical team would constitute the "ground truth." There is no indication of multiple independent readers or complex adjudication schemes like 2+1 or 3+1 as would be seen for subjective image interpretation.

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 (comparing human readers with and without AI assistance on medical cases) is relevant for AI-powered diagnostic devices, not for physical medical devices like examination gloves.

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

• Not applicable. There is no algorithm or AI component to this device. The performance is the intrinsic material performance of the glove itself.

7. The Type of Ground Truth Used

• For physical properties: Measurement against engineering specifications and industry standards (e.g., freedom from pinholes, dimensions, tensile strength).
• For chemical permeation: Objective measurement of breakthrough time using standardized chemical testing methods (ASTM D6978-05).
• For biocompatibility (dermal irritation/sensitization): Clinical observation of human subjects for skin reactions following a standardized protocol (Modified Draize-95 Test) and in-vitro/in-vivo biological evaluations per ISO 10993. The "ground truth" is the observed biological response or lack thereof.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI/ML models that require a "training set."

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

• Not applicable. As there is no AI/ML component, there is no training set or ground truth establishment for a training set.

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The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.

Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).

The provided document describes the acceptance criteria and results of non-clinical testing for "Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K240072). This is a physical medical device (gloves), not an AI/ML powered device. Therefore, questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, sample size for training sets, number of experts for ground truth, adjudication methods) are not applicable.

Here's the relevant information from the document:

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

Breakthrough Detection Time (BDT) for Chemotherapy Drugs and Fentanyl Citrate:

Please refer to the tables provided in pages 3, 4, 7, and 8 of the document for the detailed BDT for each specific chemotherapy drug and Fentanyl Citrate for both Blue and Purple-Blue gloves. The general acceptance criterion implied is that the gloves provide a certain level of protection (BDT), and the performance reports these measured BDTs. Notably, for Carmustine and Thiotepa, the BDTs are explicitly called out as "extremely low permeation times" with a warning not to use them with these drugs.

2. Sample sized 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 non-clinical test (e.g., number of gloves tested for physical dimensions, chemotherapy permeation, etc.). However, these tests are generally conducted by manufacturers according to standardized protocols (e.g., ASTM standards) which define the required sample sizes for each test. The provenance specific to the data (e.g., country of origin, retrospective/prospective) is not detailed for these non-clinical bench tests. These are laboratory tests on the product itself.

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 device submission (nitrile examination gloves) and not an AI/ML-powered device that would require expert-established ground truth from medical imaging or similar data. The acceptance criteria are based on defined physical and chemical properties measured through standardized bench tests.

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

Not applicable. Adjudication methods are typically associated with human review of data, especially in clinical or AI/ML studies, to establish ground truth. This document pertains to non-clinical bench testing of a physical product.

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, and no MRMC study was conducted.

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 concensus, pathology, outcomes data, etc)

The "ground truth" for this device is established through performance against recognized industry standards (e.g., ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series). These standards define objective, measurable physical, chemical, and biological properties of the gloves. For example, breakthrough detection time for chemotherapy drugs is a direct measurement based on established laboratory procedures.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" in the context of AI/ML.

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

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

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Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs 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, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided documentation describes the non-clinical performance testing of a medical device, specifically Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598). The study aims to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K223713).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by various ASTM and ISO standards, and the reported performance indicates that the device passed these criteria. The key performance metrics are related to physical dimensions, physical properties (tensile strength, elongation), freedom from holes, residual powder, permeation by chemotherapy drugs and fentanyl citrate, and biocompatibility.

Important Note on Chemotherapy Drugs: The document explicitly states: "Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and Thiotepa: 0 minute. Warning: Do not use with Carmustine and Thiotepa." This means that while the glove was tested against these drugs, its performance for them is below the typical acceptable threshold for chemotherapy gloves (which is usually >240 minutes for other drugs), and this is a critical aspect of its labeling and intended use.

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

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) used for each performance test. It only refers to the standards (e.g., ASTM D6319-19, ASTM D6978-05), which would specify the required sample sizes for testing. For instance, ASTM D6319-19 defines AQL (Acceptable Quality Level) for certain tests (e.g., G-I, AQL 2.5 for water leak test), which implies specific sampling plans.
• Data Provenance: The tests were non-clinical performance studies. The data provenance is linked to the manufacturer, Anhui Intco Medical Products Co., Ltd., China. The tests are described as having been "conducted to verify that the proposed device met all design specifications," implying a prospective testing approach within a laboratory setting, rather than retrospective analysis of existing data.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance (e.g., tensile strength, breakthrough time, freedom from holes) is established through standardized laboratory testing methods (ASTM, ISO), not through expert consensus or clinical judgment of images or patient data. The results are objective, measurable physical properties and chemical resistance.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation, where human readers might disagree, and a consensus or majority opinion is needed to establish ground truth. For the physical and chemical performance tests of gloves, the results are quantitative and objective, determined by laboratory equipment and standardized procedures.

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 AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a medical glove, a physical barrier, not a diagnostic tool requiring human interpretation with or without AI assistance.

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

No, this is not applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate. The tests performed are on the physical properties and chemical resistance of the glove itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Standardized Measurement: Directly measurable physical properties (e.g., length, width, thickness, tensile strength, elongation, residual powder).
• Controlled Chemical Permeation Tests: Breakthrough detection times for specific hazardous chemicals (chemotherapy drugs, fentanyl citrate).
• Biological Testing: In-vivo (animal) and in-vitro tests for biocompatibility (skin irritation, sensitization, acute systemic toxicity) as defined by ISO standards.

Essentially, the "ground truth" is defined by the established and validated protocols of the cited ASTM and ISO standards for testing medical gloves.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (a glove) that undergoes manufacturing processes and performance testing, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.

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

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

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The Powder-Free Nitrile 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.

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)

The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for "Powder Free Nitrile Examination Gloves." These documents do not contain information related to software or AI-powered medical devices. Therefore, I cannot extract details about acceptance criteria or supporting studies for such a device.

The information you've requested (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in documentation for AI/Software as a Medical Device (SaMD) products, reflecting their performance evaluation.

This submission is for a Class I medical device (non-powdered patient examination glove), which is a physical product and does not involve AI or algorithms requiring the type of performance study details you've outlined.

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