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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.

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

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

The provided document lists various performance criteria for the Nitrile Powder Free Examination Gloves (Black and Orange) and reports the results against these criteria.

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

• Sample Size for Physical/Dimensional/Chemical Tests: For "Freedom From Holes," the sampling size is stated as 125 pieces (Ac: 7, Re: 8). The specific sample size for other physical/dimensional tests (length, width, thickness, tensile strength, elongation, residual powder content) is not explicitly stated, but the tests are reported as meeting ASTM D6319-19 and ASTM D6124-06 requirements. For Biocompatibility tests, no specific sample size is given, but the studies involve guinea pigs and rats, implying animal testing was conducted.
• Sample Size for Chemotherapy Drug Permeation Tests: Not explicitly stated within the document. The tests are reported as per ASTM D6978-05 (Reapproved 2019).
• Data Provenance: The manufacturing company is Dehai (Shandong) Medical Gloves, Co., Ltd. located in Zibo City, Shandong Province, China. The testing would presumably have been conducted in a laboratory, potentially in China or a third-party testing facility. The document doesn't specify if the data is retrospective or prospective, but testing of device performance characteristics is generally prospective for regulatory submissions.

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

Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO). There is no "ground truth" established by human experts in the way an AI diagnostic algorithm would require. The "ground truth" is defined by the objective metrics and thresholds specified in the referenced ASTM and ISO standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus ground truth in studies involving human interpretation (e.g., radiology reads). This document pertains to physical and chemical testing of a medical device against predefined standards, which does not involve such 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 document is for a medical glove, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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 AI system.

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

The "ground truth" for this device's performance is based on established industry standards and objective material properties. Specifically:

• ASTM D6319-19: Standard specification for Nitrile Examination Gloves.
• ASTM D5151-19: Standard test methods for detection of holes in medical gloves.
• ASTM D6124-06: Standard test method for residual powder on medical gloves.
• ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
• ISO 10993-23, ISO 10993-10, ISO 10993-11: Biocompatibility standards for medical devices (Primary Skin Irritation, Skin Sensitization, Acute Systemic Toxicity).

These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough time for drugs).

8. The sample size for the training set

Not applicable. This device is a medical glove, not a machine learning model, so there is no training set.

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

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. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) 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 D6319-19 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 glove has biodegradation property within landfills tested per ASTM D5511.

The acceptance criteria for the Biodegradable Nitrile Powder Free Examination Gloves and their reported performance are detailed in the provided document.

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 exact sample sizes for each test mentioned (e.g., number of gloves tested for each specific drug permeation, or for physical properties). However, it references established ASTM and ISO standards for these tests. These standards typically define the sampling plans and statistical requirements for demonstrating compliance. The data provenance is derived from non-clinical laboratory testing (in-vitro studies) performed by the manufacturer or a contracted lab, rather than human test subjects or clinical data. There is no information on the country of origin of the data.

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

This section is not applicable. The device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biological tests (e.g., ASTM D6319, ASTM D6978, ISO 10993 series). The "ground truth" for these tests is established by the well-defined methodologies and acceptance criteria outlined in these international standards, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation tasks where human readers' opinions are combined to establish a ground truth. For the non-clinical performance testing of a medical device like examination gloves, the determination of compliance is based on objective measurements against established standard criteria, not on adjudicating expert opinions.

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 section is not applicable. No MRMC study was conducted as this device is an examination glove, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This section is not applicable. The device is an examination glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used

The "ground truth" for the performance evaluation of these gloves is based on standardized test methodologies and their defined acceptance criteria. This includes:

• Physical performance standards: ASTM D6319-19 for mechanical properties like length, palm width, thickness, tensile strength, and elongation.
• Leakage detection standards: ASTM D5151-19 for watertight integrity.
• Chemical permeation standards: ASTM D6978-05 (2019) for breakthrough detection time of chemotherapy drugs and other chemicals.
• Biocompatibility standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (skin irritation).

These standards provide objective, measurable criteria for the device's performance.

8. The sample size for the training set

This section is not applicable. The document describes the non-clinical performance testing of a physical medical device (examination gloves), not an AI or machine learning model. Therefore, there is no concept of a "training set" for an algorithm.

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

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

Ask a specific question about this device

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 and Fentanyl Citrate using ASTM D6978-05(2019)

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) 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 D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.

This document is a 510(k) summary for the Syntex Healthcare Products Co., Ltd.'s "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

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

The device's performance is primarily evaluated against recognized standards for medical examination gloves and specific tests for chemical permeation.

Note on Chemotherapy Permeation: For Carmustine and Thio Tepa, the reported breakthrough detection times (12.9 minutes and 35.6 minutes respectively) are explicitly noted as "extremely low permeation times" and a warning is issued: "Do not use with Carmustine and Thio Tepa." This indicates that for these specific drugs, the device does not meet an implicit "long duration" acceptance criterion and thus, limitations are clearly stated for safe use.

The study that proves the device meets (or defines limitations for) these criteria is a Summary of Non-Clinical Performance Data (Section 7 and 10 of the provided document).

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of gloves for physical dimensions, individual tests for chemotherapy permeation, or biological evaluations). However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes for testing to ensure statistical validity.

The data provenance is from Syntex Healthcare Products Co., Ltd., located at No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China. These are retrospective tests conducted by the manufacturer as part of the premarket notification (510(k)) submission process.

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. For non-clinical performance data like material testing and chemical permeation, "experts" in the sense of clinical decision-makers (e.g., radiologists) are not typically involved in establishing ground truth. The ground truth is objective, defined by the parameters of the test methods (e.g., measuring glove dimensions, detecting chemical breakthrough, evaluating cellular response). The tests are performed by personnel trained in the specific methodologies, likely in a laboratory setting.

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

An adjudication method (like 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, often when establishing a ground truth from multiple reviewers. Since these are non-clinical laboratory tests with objectively measurable outcomes (e.g., min/mm measurements, detection of chemical permeation, biological response), an adjudication method is not applicable and therefore, none was used. The "ground truth" is determined by the direct results of the standardized 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:

No MRMC comparative effectiveness study was done. This type of study is completely irrelevant for a medical device such as examination gloves, which do not involve human readers or AI assistance in their function or evaluation.

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

No standalone algorithm-only performance assessment was done. This device is an examination glove, not an AI or software-based medical device.

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

The ground truth for the non-clinical tests is based on objective measurements and observations according to established ASTM and ISO standards and methodologies.

• Physical properties and dimensions: Direct physical measurements.
• Chemical permeation: Detection of the breakthrough of specific chemicals through the glove material using analytical methods defined in ASTM D6978-05 (2019).
• Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) tests with defined endpoints and criteria.
• Bioburden: Microbiological testing to quantify microorganism levels.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning device, so there is no "training set." The data presented is from non-clinical performance testing of the final product.

9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply here.

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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 and Fentanyl Citrate using ASTM D6978-05(2019)

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) 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 D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Nitrile Powder Free Examination Gloves, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug and Fentanyl Citrate Permeation (Breakthrough Detection Time - BDT)

Note on Permeation Acceptance: For chemotherapy drugs where the predicate device showed ">240 minutes", the proposed device also achieving ">240 minutes" indicates it meets or exceeds the previous performance. For Carmustine and Thiotepa, while the BDT is lower, the acceptance is ultimately related to the explicit warning not to use them with these drugs, indicating that the observed breakthrough times are treated as insufficient for safe handling.

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

The document does not specify the exact sample sizes used for each individual test against the acceptance criteria (e.g., number of gloves tested for each physical dimension, water leak, or permeation). However, it implies standardized testing according to relevant ASTM and ISO standards. The data provenance is industrial testing, most likely performed in a lab setting, to comply with the specified ASTM and ISO standards.

• Data Provenance: The device manufacturer, Better Care Plastic Technology Co., Ltd. (located in Shenze County, Hebei, China), would have overseen these tests, either internally or through a qualified testing laboratory. The data is thus of industrial origin, specifically from the manufacturer's testing or a third-party lab they used.
• Retrospective/Prospective: These are likely prospective tests conducted specifically for this 510(k) submission to demonstrate compliance with the standards.

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

This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective, standardized laboratory tests (e.g., measuring physical dimensions, tensile strength, breakthrough detection time for chemicals, biological reactivity as per ISO standards). It does not involve human expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where expert opinions need to be reconciled. For the physical and chemical testing of gloves, the results are quantitative measurements or direct observations (e.g., pass/fail for a water leak test) and do not require expert adjudication in the same sense.

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

This is not applicable. An MRMC study assesses the performance of human readers (e.g., radiologists, pathologists) in interpreting medical data, often with and without AI assistance, across a range of cases. This device (examination gloves) is a physical product and does not involve human readers or AI assistance in its primary function, nor in the testing performed for its clearance.

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

This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by:

• Standardized Test Methods and Specifications: Specific values and criteria (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough detection time) defined by national and international standards like ASTM D6319-19, ASTM D6978-05, ISO 10993 series.
• Direct Measurement and Observation: The device's physical properties and chemical resistance are directly measured and observed in laboratory settings according to these established protocols.
• Biological Reactivity Endpoints: For biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity), the "ground truth" is determined by established biological endpoints and criteria within the ISO 10993 standards.

8. The sample size for the training set

This is not applicable. This question refers to the training data for an AI algorithm. This device is a physical medical product, and no AI algorithm development is described or relevant to its clearance.

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

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

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable 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 colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: extra-small, small, medium, large, and extra-large.

The provided document describes the FDA 510(k) premarket notification for "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)". This document is for a medical device (gloves), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of acceptance criteria for AI performance, training/test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or a sample size for training data are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical and chemical performance standards for the gloves, particularly their resistance to chemotherapy drugs and biocompatibility.

Here's the information extracted from the provided text, tailored to the context of a physical medical device:

Acceptance Criteria and Device Performance for Disposable Nitrile Powder-Free Examination Gloves

The acceptance criteria for the Disposable Nitrile Powder-Free Examination Gloves are based on compliance with established international and national standards for medical gloves, particularly regarding their physical properties, freedom from holes, residual powder content, and resistance to permeation by chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

• Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes
• Dacarbazine 10 mg/ml: > 240 Minutes
• Doxorubicin 2.0 mg/ml: > 240 Minutes
• Etoposide 20.0 mg/ml: > 240 Minutes
• Fluorouracil 50.0 mg/ml: >240 Minutes
• Paclitaxel 6.0 mg/ml: >240 Minutes
• Thio Tepa 10.0 mg/ml: 46.8Minutes (min.) | Reported Breakthrough Detection Times: (Matches acceptance criteria values exactly, indicating compliance).
• Carmustine (BCNU) 3.3 mg/ml: 22.8(23.7, 22.8, 23.1) Minutes
• Cisplatin 1.0 mg/ml: > 240 Minutes
• Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes
• Dacarbazine 10 mg/ml: > 240 Minutes
• Doxorubicin 2.0 mg/ml: > 240 Minutes
• Etoposide 20.0 mg/ml: > 240 Minutes
• Fluorouracil 50.0 mg/ml: >240 Minutes
• Paclitaxel 6.0 mg/ml: >240 Minutes
• Thio Tepa 10.0 mg/ml: 46.8(48.2, 48.6, 46.8) Minutes.
  Warning: Low permeation times for Carmustine (BCNU) and Thio Tepa are noted, with a warning not to use with these specific drugs given their breakthrough times. |

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

The document describes material and performance testing, not a "test set" in the sense of an AI model's dataset. The "samples" refer to physical gloves selected for testing.

The provenance of the data is from laboratory testing conducted on the manufactured gloves. The specific country of origin for the testing itself is not explicitly stated, but the manufacturer is Shandong Maida Medical Technology Co.,Ltd. in China. The testing is prospective in the sense that newly manufactured gloves are tested to ensure they meet the standards.

• ASTM D5151 (Detection of Holes): Sample size for water leakage test: 125 gloves.
• ASTM D6319 (Dimensions & Physical Properties): Results are shown for multiple lots (e.g., Lot no.: 210515, 210518, 210520), indicating multiple samples were tested across different manufacturing batches. The exact number of gloves per lot for each physical test (e.g., tensile strength, elongation) is not specified but would be defined by the ASTM standard.
• ASTM D6978 (Chemotherapy Permeation): The results provide triplet values for Carmustine and Thio Tepa (e.g., 22.8(23.7, 22.8, 23.1)), suggesting three independent measurements were taken for these drugs. The standard itself specifies the number of replicates.
• Biocompatibility Testing: The number of animal subjects used for the animal irritation, sensitization, and systemic toxicity tests is not specified in the summary but would conform to the respective ISO standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the evaluation involves standardized laboratory testing against defined physical and chemical properties, not human expert interpretation of subjective data or images. The "ground truth" is defined by the objective measurement results according to the specified ASTM and ISO standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in human expert assessments (e.g., in medical image interpretation). Here, numerical test results from standardized methods are directly compared against established quantitative or qualitative acceptance criteria.

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

This is not applicable. MRMC studies are used to evaluate diagnostic imaging systems or AI tools where human readers are involved. This submission is for a physical medical glove.

6. Standalone (Algorithm Only) Performance

This is not applicable. This concept applies to AI/software performance. The device is a physical glove, not an algorithm.

7. Type of Ground Truth Used

The ground truth used is based on objective, quantitative measurements derived from standardized laboratory tests (bench testing) and biological responses observed in validated biocompatibility assays according to international standards (ASTM and ISO). This includes:

• Quantitative Thresholds: e.g., minimum tensile strength, maximum residual powder, minimum breakthrough time for chemotherapy drugs.
• Qualitative Observations (Biological): e.g., absence of irritation or sensitization, absence of systemic toxicity.
• Conformity to Standards: The device's performance is compared directly to the specified requirements within each standard (e.g., ASTM D6319-19 dimensions, physical properties).

One point of note is the cytotoxicity result (17.1% viability) which is below the 70% threshold, indicating cytotoxicity. The document addresses this by stating: "Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test." And the systemic toxicity test showed "no evidence of systemic toxicity." This implies that despite the in vitro cytotoxicity, the manufacturer argues that in vivo systemic toxicity (which is generally considered a more critical endpoint for patient safety) was not observed, suggesting the findings are acceptable for the device's intended use according to the biocompatibility evaluation framework.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a physical device. The manufacturing process is controlled to produce gloves consistently, and batch testing ensures quality.

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

This is not applicable. As there is no training set, the establishment of ground truth for it is irrelevant. The manufacturing process is designed and verified to produce products meeting the specified design and performance criteria.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable 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 colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

This document describes the acceptance criteria and the study proving that the "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The device was tested against several standards, as detailed in the "Summary of Non-Clinical Testing" section (pages 8-13). Here's a summary:

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

The document provides the following details:

• ASTM D5151 (Freedom from Holes): Sample size of 125 gloves. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated but is implied to be from laboratory testing conducted as part of the regulatory submission process.
• For other tests (Biocompatibility, Physical Properties, Chemotherapy Drug Permeation), specific sample sizes are not detailed in the provided text. However, testing was stated to be "in accordance with the following standards" (ISO and ASTM), which would implicitly define minimum sample sizes for each test method. Data provenance is implied to be from laboratory testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The tests conducted are laboratory-based and follow established international and national standards (ISO, ASTM). The "ground truth" for these tests is defined by the methodologies and performance requirements within these standards, not by expert consensus in a clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are laboratory performance tests following well-defined standards, not clinical studies requiring independent adjudication of outcomes.

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

This information is not applicable as the device is a medical glove, and the studies are pre-market non-clinical performance and biocompatibility evaluations. It is not an AI-assisted diagnostic device or a device where human reader performance would be a relevant metric.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is the physical and chemical resistance of the glove itself.

7. Type of Ground Truth Used:

The ground truth for the evaluations is based on:

• Standardized Laboratory Test Results: Defined by the methodologies and acceptance criteria specified in the referenced ASTM and ISO international standards (e.g., specific tensile strength values, breakthrough times, chemical concentrations).
• Biocompatibility Endpoints: As defined by ISO 10993 standards (e.g., absence of irritation, sensitization, systemic toxicity).

8. Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards. Gloves is direct contact and not to be worn for more than 24 hours.

The subject device is Sterile Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs And Fentanyl Citrate (Blue). The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-11 and permeability to chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05(2019).

This document is a 510(k) premarket notification for "Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)". It details the device's characteristics, performance, and comparison to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is tested against various physical properties and chemical permeation criteria.

Physical Properties (based on ASTM D6319-19):

Chemotherapy Drug and Fentanyl Citrate Permeation (based on ASTM D6978 standards):

Note: For Carmustine and Thiotepa, the document explicitly states warnings due to low permeation times, even though they have a reported BDT.

Biocompatibility Studies (ISO 10993-10, ISO 10993-11, ISO 10993-5):

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

The document specifies the standards used for testing, which implicitly defines the sample sizes and testing methodologies. However, it does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for each chemotherapy drug).

• Standards Used: ASTM D6319-19 (for dimensions, physical properties, freedom from holes, powder content) and ASTM D6978-05(2019) (for permeability to chemotherapy drugs and Fentanyl Citrate). Biocompatibility testing was done per ISO 10993-10, ISO 10993-11, and ISO 10993-5.
• Data Provenance: Not explicitly stated, but based on the owner's identification (Grand Work Plastic Products Co., Ltd. in Hebei, China) and the contact information (Hongray USA Medical Products Inc. in Chino, California), the testing was likely conducted by or for the manufacturer, potentially in China or a contracted lab. The data is retrospective for the purpose of this 510(k) submission, as the tests have already been performed.

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

This question is not applicable as the document describes the testing of physical and chemical properties of gloves against established industry standards. The "ground truth" here is the performance requirement defined by these standards, not expert consensus on medical images or clinical outcomes. The tests are objective measurements, not subjective expert interpretations.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, quantitative measurements against predefined specifications (e.g., minimum length, minimum tensile strength, breakthrough detection time). There is no "adjudication" in the sense of reconciling differing expert opinions.

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 submission for sterile nitrile examination gloves, not an AI-powered diagnostic device. No human readers or AI assistance are involved in the performance evaluation of the gloves.

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

Not applicable. This is a physical medical device (gloves), not an algorithm.

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

The "ground truth" for the device's performance is objective, laboratory-measured data based on established international standards:

• Physical properties (dimensions, strength, elongation, hole detection, powder content) are measured quantitatively according to ASTM D6319-19, ASTM D5151-19, and ASTM D6124-06(2017).
• Chemical permeation (breakthrough detection time for chemotherapy drugs and Fentanyl Citrate) is measured according to ASTM D6978-05(2019).
• Biocompatibility (skin irritation, sensitization, systemic toxicity, cytotoxicity) is assessed using in vitro and in vivo tests guided by ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. This is a physical medical device, not a machine learning model.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

This is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs. This document does not describe the acceptance criteria and study for an AI/ML device. Instead, it focuses on the performance characteristics of medical gloves, particularly their resistance to chemotherapy drugs.

Here’s a breakdown of the information provided, re-interpreting some fields for a non-AI/ML medical device where applicable, and highlighting what is missing in the context of your request for an AI/ML device:

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

The document provides several tables detailing the performance of the gloves.

Permeation by Chemotherapy Drugs (Key Performance Claim):

Other Non-Clinical Testing Results (from Table 2 and Table 3):

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 Chemo Permeation: Not explicitly stated as a single number. The testing is done "in accordance with ASTM D6978-05" which specifies test methods. While not clearly itemized in the summary, typical ASTM D6978 testing involves multiple specimens per drug.
• Sample Size for Biocompatibility: Not explicitly stated, but standard ISO 10993 tests involve specific numbers of samples/animals or cell cultures as per the standard.
• Sample Size for Physical Tests (e.g., Holes, Dimensions, Tensile Strength): For "Freedom from Holes," the results show "S:0/125 leaks", "M:0/125 leaks", "L:0/125 leaks", "XL:0/125 leaks," implying a sample size of 125 gloves per size for this test. Other physical tests (dimensions, tensile strength) are usually performed on a representative sample set as per the ASTM standards.
• Data Provenance: Not specified whether the tests were conducted in China (where the manufacturer is located) or another country. The testing methods used are international ASTM and ISO standards. It's a prospective series of tests conducted on the manufactured device.

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 section is Not Applicable to this type of device (medical gloves). The "ground truth" for medical gloves is established through objective physical and chemical testing against recognized national and international standards (ASTM, ISO), not through expert clinical consensus or interpretation of medical images.

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

This is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to resolve discrepancies, typically for AI/ML diagnostic tools. For physical devices like gloves, performance is measured objectively against predefined criteria.

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. An MRMC study is relevant for AI/ML diagnostic or assistive technologies where human readers are involved in interpretation. This document describes physical, non-AI/ML device performance.

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

This is Not Applicable. This device is not an algorithm or AI.

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

The "ground truth" for this device is established by:

• Objective physical measurements: e.g., length, width, thickness, tensile strength, elongation, powder content.
• Objective chemical permeation testing: measuring breakthrough time of chemotherapy drugs using analytical methods as specified in ASTM D6978-05.
• Biocompatibility assays: in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) tests as per ISO 10993 standards.

These are validated laboratory test methods, not expert consensus or clinical outcomes data in the usual sense for diagnostic devices.

8. The sample size for the training set

This is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to physical performance testing of a manufactured product.

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

This is Not Applicable. As it's not an AI/ML device, there is no training set or corresponding ground truth establishment process in the context of your request.

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Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotheraty Drugs and Fentany Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Cliemotherapy Drugs and Fentanyl Citrate

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

This document is a 510(k) clearance letter for "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It details the device's indications for use and performance related to permeation by chemotherapy drugs and Fentanyl Citrate.

Here's the breakdown of the 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 implied by the standard ASTM D6978-05 (Reapproved 2013) and the reported minimum breakthrough detection times for various chemotherapy drugs and Fentanyl Citrate. The goal is to demonstrate that the gloves provide a protective barrier for a sufficient duration. The reported performance refers to the breakthrough times achieved during testing.

Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 21.4 minutes and 67.2 minutes respectively. Warning: Do not use with Carmustine". This implies that while the device was tested against Carmustine, its low breakthrough time means it does not meet a practical "acceptance" for safe use with that particular drug, leading to a specific warning. For other drugs, a breakthrough time of >240 minutes indicates good 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 specify the sample size used for the test set (number of gloves or repetitions per drug). It also does not explicitly state the data provenance or whether the study was retrospective or prospective. The testing was conducted "as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," which is a standardized testing method.

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 the physical permeation of chemicals through the glove material, measured in a laboratory setting using analytical techniques as defined by the ASTM standard. It does not involve expert interpretation or consensus.

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

Not applicable. This study involves objective laboratory measurements, not subjective evaluations 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 is a study on the barrier effectiveness of gloves against chemical permeation, not an AI-assisted diagnostic study involving human readers.

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

Not applicable. This document describes a physical performance test of a medical device (gloves), not an algorithm or AI system.

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

The "ground truth" is the empirically measured breakthrough time of various chemotherapy drugs and Fentanyl Citrate through the glove material, determined according to the methodologies outlined in ASTM D6978-05. This is a direct physical measurement.

8. The sample size for the training set

Not applicable. This refers to the testing of a physical medical device, not a machine learning model that requires a training set.

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

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

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The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.

KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.

This document is a 510(k) Premarket Notification for KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves. It focuses on demonstrating that the proposed device is substantially equivalent to legally marketed predicate devices, particularly concerning its resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the permeation resistance of the gloves are defined by the "Minimum Breakthrough Detection Time" for each substance. For other characteristics, the acceptance criteria are generally "Complies with" or "Pass" based on recognized ASTM and ISO standards.

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