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The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, 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 drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Bleomycin sulfate (15.0 mg/ml 15,000 ppm) 240 min Carboplatin (10.0 mg/ml 10,000 ppm) 240 min Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 26.7 Cisplatin (1.0 mg/mL 1,000 ppm) 240 min Cyclophosphamide (20.0 mg/mL 20,000 ppm) 240 min Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) 240 min Dacarbazine (10.0 mg/mL 10,000 ppm) 240 min Doxorubicin HCL (2.0 mg/mL 2,000 ppm) 240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) 240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) 240 min Idarubicin (1.0 mg/ml 1,000 ppm) 240 min Ifosfamide (50.0 mg/mL 50,000 ppm) 240 min Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) 240 min Methotrexate (25.0 mg/mL 25,000 ppm) 240 min Mitomycin C (0.5 mg/mL 500 ppm) 240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm 240 min Paclitaxel (6.0 mg/mL 6,000 ppm) 240 min Thiotepa (10.0 mg/mL 10,000 ppm) 37.6 Vincristine Sulfate (1.0 mg/mL 1,000 ppm 240 min Non Chemotherapy Drug MESNA (100.0 mg/mL 100,000 ppm) 240 min Trisenox (1.0 mg/ml 1,000 ppm) 240 min Fentanyl Citrate Injection (100 mcg/2mL) 240 min Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa.

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in four sizes, small, medium and large, extra-large, packed in a paper box. The 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 (Reapproved 2019). The gloves are as same as the Nitrile disposable examination gloves (Model D5000) cleared under K212578 also produced by Xingyu Medical Tech Co., Ltd. The materials and the manufacturing process technology are the same. The proposed device is increased test of Chemotherapy Drug and Fentanyl. Testing has been conducted on the proposed device passed as per ASTM D6978-05 (Reapproved 2019).

This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl". It does not describe an AI medical device. Therefore, I cannot provide an answer based on the prompt's request for AI-specific acceptance criteria and study details.

The document focuses on the physical and chemical properties of medical gloves, their resistance to certain drugs, and their biocompatibility, which are assessed through standard laboratory testing methods, not AI performance studies.

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The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.

Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.

The tested chemotherapy drugs are:

Chemotherapy drug Concentration Minimum Breakthrough Detection Time

Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min

Carboplatin (10.0 mg/ml 10,000 ppm) >240 min

Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2

Cisplatin (1.0 mg/mL 1,000 ppm) >240 min

Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min

Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min

Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min

Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min

Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min

Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min

Idarubicin (1.0 mg/ml 1.000 ppm) >240 min

Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min

Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min

Methotrexate (25.0 mg/mL 25,000 ppm) >240 min

Mitomycin C (0.5 mg/mL 500 ppm) >240 min

Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min

Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min

Thiotepa (10.0 mg/mL 10,000 ppm) 13.1

Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min

The tested non-chemotherapy drugs are:

Fentanyl Citrate Injection (100 mcg/2mL) >240 min

MESNA (100.0 mg/mL 100,000 ppm) >240 min

Trisenox (1.0 mg/ml 1,000 ppm) >240 min

Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.

Warning: Do Not Use with Carmustine, Thiotepa

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.

The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.

This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)". It outlines the device's characteristics, indications for use, and a comparison to a predicate device, focusing on non-clinical testing.

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

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

The document provides multiple tables summarizing the performance and comparison of the proposed device to predicate devices. The primary table serving this purpose is "Table 3 Performance comparison" and the table that includes "Test Method," "Purpose," "Acceptance Criteria," and "Results" on Page 13.

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 exact sample sizes used for each physical or chemical test. It references ASTM standards, which would typically define sampling plans. For instance, for Freedom from Holes, it mentions "sampling level of G-1, AQL 2.5," which refers to specific statistical sampling plans within ASTM D5151, but not the explicit number of gloves tested.

The data provenance is from non-clinical tests conducted to relevant ASTM and ISO standards. The Applicant, Shandong Xingyu Gloves Co., Ltd., is located in China, suggesting the tests were likely conducted there or by affiliated labs. The testing appears to be prospective as it was done specifically to evaluate the performance of this new device for submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience).

This document describes a device (gloves) and its performance under various physical and chemical stress tests, not imaging or diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the medical image interpretation sense (e.g., radiologists) is not applicable here. The "ground truth" for the performance claims (e.g., tensile strength, breakthrough time) is established by adherence to the specified and validated ASTM and ISO laboratory test methods and their defined measurement protocols. The experts involved would be the qualified laboratory technicians and chemists performing these standardized tests. Their qualifications are implicitly that they are capable of performing these standardized tests correctly.

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

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving subjective human interpretation of data (e.g., medical images), where disagreements between readers need to be resolved by a third or fourth expert. Since this document describes non-clinical, objective laboratory testing of physical and chemical properties, an adjudication method as typically understood in a multi-reader clinical study is not applicable. The results are directly measured by instruments and adherence to test protocols.

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

No, an MRMC comparative effectiveness study was not conducted. This is a 510(k) submission for medical gloves, based on non-clinical performance testing against established standards, not a diagnostic AI device requiring human reader interaction studies.

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

No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance claims is based on objective measurements obtained through standardized laboratory test methods (ASTM and ISO standards). For example:

• Physical properties (tensile strength, elongation): Measured in a lab according to ASTM D6319.
• Freedom from holes: Tested by inflation or water leak methods per ASTM D5151.
• Residual powder: Measured gravimetrically per ASTM D6124.
• Permeation by chemotherapy drugs/Fentanyl: Measured chromatographically by detecting breakthrough according to ASTM D6978.
• Biocompatibility: Evaluated in in vitro or in vivo models for specific biological endpoints (irritation, sensitization, systemic toxicity) following ISO 10993 standards.

The ground truth is therefore defined by the quantitative and qualitative results of these standardized, validated test procedures.

8. The sample size for the training set.

There is no training set mentioned or implied because this is not an AI/machine learning device. The device's performance is demonstrated through standard laboratory testing, not by training a model on a dataset.

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

As there is no training set, this question is not applicable.

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The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue, powder free, nitrile gloves. The gloves are offered in sizes small, medium, large, extra large, and packaged in a color paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05(2019).

This document is a 510(k) Premarket Notification for Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs). As such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on the performance of an AI/ML powered medical device. Therefore, a significant portion of the requested information (points 2-5, 7-9) about the study design for an AI/ML powered device is not applicable to this document.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The device meets acceptance criteria across several tests, primarily based on ASTM standards.

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

• Sample Size for Test Set:
  • For the Watertightness Test (detection of holes), the sample size was 125 gloves for a batch size of 35,000.
  • For other physical and chemotherapy permeation tests, the specific sample sizes are not explicitly stated within the provided text, but they were conducted "per ASTM D6319-19" and "per ASTM D6978-05(2019)", implying adherence to the sample size requirements of those standards.
• Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the independent labs performing the tests are located) or whether the studies were retrospective or prospective, though performance testing is inherently prospective for a new device. The submitter is XINGYU MEDICAL TECH CO.,LTD. from China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. This document describes performance testing of medical gloves against established ASTM and ISO standards for physical properties, chemotherapy permeation, and biocompatibility. Ground truth in this context is determined by laboratory measurements and chemical/biological assays, not by expert interpretation of images or clinical data.

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

This information is not applicable. As mentioned above, the assessment criteria are based on objective, standardized laboratory tests, not subjective expert judgment that would require an adjudication method.

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

This information is not applicable. This document is for medical gloves, not an AI/ML powered device.

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

This information is not applicable. This document is for medical gloves, not an AI/ML powered device.

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

The "ground truth" for the device's performance is established by objective measurements and observations derived from standardized laboratory tests:

• Physical Measurements: Length, width, and thickness measured according to ASTM D6319-19.
• Mechanical Property Tests: Tensile strength and elongation measured before and after aging according to ASTM D6319-19.
• Watertightness Test: Detection of holes by visual inspection after inflation or water fill, according to ASTM D5151-19.
• Chemical Analysis: Residual powder measured according to ASTM D6124-06 (2017).
• Permeation Testing: Breakthrough time of chemotherapy drugs measured using a sensitive analytical method (e.g., gas chromatography, liquid chromatography) to detect the permeation of the drug through the glove material (as per ASTM D6978-05(2019)).
• Biocompatibility Assays: In-vitro or in-vivo tests to assess skin irritation (e.g., patch tests on animals or human volunteers), dermal sensitization (e.g., guinea pig maximization test), and acute systemic toxicity (e.g., intravenous or oral administration to animals), according to ISO 10993-10 and ISO 10993-11.

8. The sample size for the training set

This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set."

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

This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set" or ground truth establishment for such a set.

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Nitrile disposable examination gloves are 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.

Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.

This document describes the performance testing and acceptance criteria for Nitrile disposable examination gloves. It is important to note that this is a physical medical device (gloves), not an AI/software-based medical device. Therefore, many of the requested criteria in your prompt (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable to this type of device.

Here's the information extracted from the provided text, focusing on the relevant criteria for a physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The performance data is primarily presented in a comparative table against ASTM standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set:
  • For the Watertightness Test (detection of holes), the sample size is explicitly stated: 125 samples for a batch size of 35,000.
  • For other tests (Physical Dimensions, Physical Properties, Powder Residual, Biocompatibility), specific sample sizes are not detailed in the provided document. The document refers to meeting ASTM and ISO standards, which would implicitly define testing sample sizes.
• Data Provenance: The tests are described as "bench testing" and "non-clinical performance data." The company performing the tests is XINGYU MEDICAL TECH CO.,LTD., located in China. The data is retrospective in the context of the 510(k) submission, meaning the tests were completed prior to submission.

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

• Not Applicable. This is a physical device, and performance is measured against established international standards (ASTM, ISO) for physical and chemical properties, not by human expert interpretation of data or images. The "ground truth" is defined by the technical specifications and test methodologies within these standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a physical device, testing is quantitative and follows specific, standardized protocols. There is no human adjudication process involved in the interpretation of physical test results. Results are either "Pass" or "Fail" based on whether they meet the numerical acceptance criteria of the standards.

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

• No. An MRMC study is relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. This is a physical medical device (gloves), so an MRMC study is not applicable. The document explicitly states: "Clinical data is not needed to demonstrate the performance or safety of the subject glove as compared to the predicate device or applicable standards."

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

• Not Applicable. This refers to AI algorithm performance. This product is a physical glove, not an algorithm. The testing described is "standalone" in the sense that it's testing the inherent properties of the glove itself against defined standards.

7. The Type of Ground Truth Used

• The ground truth for this device's performance relies on established international consensus standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06(2017), ISO 10993-10: 2010, ISO 10993-11: 2017, ASTM D7161-16). These standards define the acceptable physical dimensions, mechanical properties (tensile strength, elongation), barrier integrity (pinholes), chemical properties (powder residual), and biocompatibility.

8. The Sample Size for the Training Set

• Not Applicable. This refers to AI algorithm training data. This product is a physical glove and does not involve machine learning or a "training set."

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

• Not Applicable. As there is no training set for a physical device like this, there is no ground truth established in this context.

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