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NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.

Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes

Warning: Not for Use with: Carmustine, ThioTEPA

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.

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 size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the watertightness test (ASTM D5151/ASTM D6319), it reports "0/125/Pass" which indicates a sample size of 125 gloves were tested for holes, and none failed.

The non-clinical tests were conducted to verify that the proposed device met all design specifications according to recognized standards. The identity of the testing laboratories or the origin of the samples is not specified in this document.

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

This document describes non-clinical performance testing of a physical device (gloves). Therefore, there is no "ground truth" derived from expert interpretation of medical images or data in the typical sense. The ground truth for these tests is established by the specified standards (ASTM and ISO standards) themselves, which outline quantitative metrics and methodologies for evaluation. No human experts are explicitly mentioned as establishing ground truth for these specific tests.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against established standards, not subjective assessments requiring adjudication or consensus among experts.

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

No. An MRMC comparative effectiveness study is not applicable to the non-clinical performance testing of medical gloves. This type of study is typically used for evaluating the effectiveness of diagnostic or prognostic medical devices that rely on human interpretation, often with AI assistance, in comparison to human interpretation alone.

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

Not applicable. This document pertains to the physical performance of medical gloves, not a software algorithm that would operate in a standalone mode.

7. Type of Ground Truth Used

The ground truth for all tests is based on established testing standards and their quantitative acceptance criteria. For example:

• Physical dimensions are compared against numerical ranges specified in ASTM D6319-19.
• Watertightness is assessed by the absence of holes per ASTM D5151-19, with an acceptable quality level (AQL).
• Powder content is measured against a maximum limit per ASTM D6124-06.
• Tensile strength and ultimate elongation are measured against minimum requirements per ASTM D6319-19.
• Chemotherapy drug permeation is determined by breakthrough detection times as per ASTM D6978-05(2023).
• Biocompatibility tests (cytotoxicity, irritation, sensitization, acute systemic toxicity) are evaluated according to ISO 10993 series standards.

8. Sample Size for the Training Set

Not applicable. This document is about a physical medical device (gloves) and its non-clinical performance testing, not an AI/ML-based device 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 device.

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The Powder free, Non-sterile, Blue Nitrile 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 to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min Cyclophosphamide (20 mg/mL 20,000 ppm) >240 min Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) >240 min Dacarbazine (10 mg/mL 10,000 ppm) >240 min Doxorubicin (Adriamycin) (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 Ifosfamide (50.0 mg/mL 50,000 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) 34.8 min Vincristine Sulfate (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 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine. Thiotepa

The Powder free, Non-sterile, Blue Nitrile 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 five sizes, extra small, small, medium, large, and 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.

The provided document describes the acceptance criteria and results for the "Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl" device.

Here's an analysis of the requested information:

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

Note on Biocompatibility: The document states that despite the in vitro cytotoxicity showing "potential toxicity," the overall biocompatibility assessment was deemed acceptable, asserting it "does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment."

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 specify the exact sample sizes used for each performance test (e.g., how many gloves were tested for dimensions, holes, tensile strength, or chemotherapy permeation). It references standards like ASTM D6319-19, ASTM D5151-19 (G-1, AQL 2.5), ASTM D6124-06, and ASTM D6978-05, which would prescribe the methodology and sample sizes.

The data provenance regarding country of origin or retrospective/prospective nature is not explicitly mentioned. The applicant, Anhui Powerguard Technology Co., Ltd., is based in China, suggesting the testing may have been conducted there or through contract labs globally.

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

This device is a physical medical device (examination gloves), not an AI/software device that requires expert interpretation of images or data to establish ground truth. Therefore, the concept of "experts used to establish ground truth" in the context of medical imaging or AI algorithms is not applicable here. The "ground truth" for this device is established by physical and chemical testing against established engineering and safety standards.

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

Similarly, as this is a physical device and not an AI/software for diagnostic interpretation, adjudication methods like 2+1 or 3+1 are not applicable. Performance is measured against quantitative criteria defined by international standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for medical gloves.

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

No, this question is not applicable. The device is a physical product (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 established by:

• International Standards: ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
• Biocompatibility Standards: ISO 10993-1, ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Dermal Sensitization), ISO 10993-11 (Acute Systemic Toxicity), and ISO 10993-23 (Primary Skin Irritation).

These standards define the methodologies and acceptance limits for evaluating the physical, chemical, and biological properties of the gloves.

Regarding In Vitro Cytotoxicity: The report notes that the "test article extract showed potential toxicity." However, the analysis in the 510(K) Summary explicitly states: "Analysis: In vitro cytotoxicity and acute systemic toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment." This indicates that while an in vitro test showed some indication, the overall biocompatibility assessment, likely considering other in vivo tests like skin irritation and sensitization which passed, led to the conclusion of acceptable biocompatibility. This implicitly uses the wider expert consensus and risk assessment methodology embedded in the ISO 10993 series of standards as the 'ground truth' for biocompatibility.

8. The sample size for the training set

This question is not applicable as this is a physical medical device, not an AI/software device that requires a training set.

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

This question is not applicable as this is a physical medical device, not an AI/software 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 and Fentanyl Citrate using ASTM D6978-05(2019).

Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) 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 gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.

The provided text describes the acceptance criteria and study results for "Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)".

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Chemotherapy Drug and Fentanyl Citrate Permeation Performance:

Black Glove:

Green Glove:

Warnings: Do not use with Carmustine and Thiotepa due to extremely low permeation times.

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

The document does not explicitly state the specific sample sizes for each test in the acceptance criteria. However, compliance with ASTM and ISO standards for products like medical gloves typically involves defined sample sizes for testing (e.g., AQL levels for freedom from holes). The data provenance is not specified, but the testing was conducted to international standards (ASTM, ISO). Given this is a 510(k) submission for a physical device (gloves), the testing is prospective, performed on the manufactured product.

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 device is a physical product (medical gloves) and its performance is evaluated against engineering and material standards (ASTM, ISO), along with chemical permeation resistance. There is no human interpretative element requiring expert consensus or ground truth in the way medical imaging AI devices do. The "ground truth" here is the result of standardized physical and chemical tests.

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

Not applicable. As this is not an AI/diagnostic device, there is no adjudication process involving human experts to establish ground truth from data.

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 medical device.

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

Not applicable. This is not an AI medical device. The tests performed are standalone in the sense that the device itself is subjected to a test, and its performance is measured directly against predefined criteria without human intervention in the result determination beyond operating the testing equipment.

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

The "ground truth" for this device's performance is established by standardized laboratory testing protocols and predefined limits specified in international standards (ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series, etc.). For example, the minimum tensile strength, elongation percentages, AQL for holes, and breakthrough detection times for chemicals are directly measured and compared against the specified numerical criteria from these standards.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning model. Therefore, 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, this question is not relevant.

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Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05.

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl

The provided document is a 510(k) clearance letter for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl." It primarily outlines the regulatory approval and indications for use, including a table of chemotherapy drugs and their breakthrough detection times.

This document does not contain the kind of information typically found in a study proving an AI/ML device meets acceptance criteria. The requested information (e.g., sample size for test set, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML-driven medical devices. The device described here is a physical product (nitrile gloves), not an AI/ML device.

Therefore, I cannot extract the requested information from the provided text.

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Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate in accordance with ASTM D6978-05(2019).

Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The provided text describes information about Black Non Sterile Powder Free Nitrile Examination Gloves, tested for use with various chemotherapy and non-chemotherapy drugs. It is a 510(k) premarket notification for a Class I device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the testing against ASTM D6978-05(2019) for breakthrough detection time for various drugs. The performance is reported as the "Breakthrough Detection Time in Minutes." The general acceptance is that gloves should resist permeation by these drugs for a significant duration, ideally greater than 240 minutes, which is a common benchmark for such tests.

Important Note: The document explicitly states a caution and warning for Carmustine and Thiotepa due to significantly lower breakthrough times (13.2 minutes and 34.7 minutes respectively), indicating these are not acceptable for extended use with these specific drugs.

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

The document does not specify the exact sample size (e.g., number of gloves tested for each drug). It mentions "average breakthrough detection time," which implies multiple samples were tested. The data provenance is testing "in accordance with ASTM D6978-05(2019)," which is a standardized testing method. The document originated from Central Medicare Sdn. Bhd. in Malaysia, suggesting the testing was likely conducted in Malaysia or under their supervision. The information is presented in a regulatory submission to the FDA, which generally implies the data is gathered for the purpose of demonstrating device safety and effectiveness. It is a report of testing, which by nature is prospective data collection for evaluating the device.

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" here is objective measurement of breakthrough time, determined by laboratory instruments and procedures as defined by the ASTM D6978-05(2019) standard, not by expert interpretation or consensus.

4. Adjudication method for the test set

This information is not applicable. As the "ground truth" is an objective measurement based on a standardized test method (ASTM D6978-05(2019)), there is no need for expert 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 information is not applicable. This document describes the performance of a physical medical device (gloves) against chemical permeation, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study or AI assistance is irrelevant.

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

This information is not applicable. This is not an algorithmic or software device. The performance data is for the physical glove itself.

7. The type of ground truth used

The ground truth used is objective laboratory measurement based on established chemical permeation testing for protective clothing materials, specifically "breakthrough detection time" according to ASTM D6978-05(2019).

8. The sample size for the training set

This information is not applicable. This is not a machine learning or AI-driven device that requires training data in the conventional sense. The device's performance is intrinsic to its material and manufacturing.

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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Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05.

Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

Fentanyl Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.

Gastric Acid Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This document is a 510(k) premarket notification from the FDA for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims."

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

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

   The "acceptance criteria" here are defined by the performance standards outlined for the permeation resistance of the gloves to various drugs. The device performance is reported as the "Breakthrough Detection Time in Minutes." The general implicit acceptance criterion for most drugs appears to be a breakthrough time of "> 240 minutes," indicating that the glove provides protection for at least 4 hours.

   Chemotherapy Drug	Concentration	Acceptance Criteria (Implicit)	Reported Device Performance (Breakthrough Detection Time in Minutes)
   Arsenic Trioxide	1.0 mg/ml	> 240 minutes	> 240 minutes
   Azacitidine (Vidaza)	25.0 mg/ml	> 240 minutes	> 240 minutes
   Bendamustine HCl	5.0 mg/ml	> 240 minutes	> 240 minutes
   Bleomycin Sulfate	15.0 mg/ml	> 240 minutes	> 240 minutes
   Busulfan	6.0 mg/ml	> 240 minutes	> 240 minutes
   Carboplatin	10.0 mg/ml	> 240 minutes	> 240 minutes
   Carmustine (BCNU)	3.3 mg/ml	> 240 minutes (Implied)	77.6 minutes
   Carfilzomib	2.0 mg/ml	> 240 minutes	> 240 minutes
   Cisplatin	1.0 mg/ml	> 240 minutes	> 240 minutes
   Cladribine	1.0 mg/ml	> 240 minutes	> 240 minutes
   Cyclophosphamide (Cytoxan)	20.0 mg/ml	> 240 minutes	> 240 minutes
   Cytarabine	100.0 mg/ml	> 240 minutes	> 240 minutes
   Dacarbazine	10.0 mg/ml	> 240 minutes	> 240 minutes
   Daunorubicin	5.0 mg/ml	> 240 minutes	> 240 minutes
   Decitibine	5.0 mg/ml	> 240 minutes	> 240 minutes
   Docetaxel	10.0 mg/ml	> 240 minutes	> 240 minutes
   Doxorubicin Hydrochloride	2.0 mg/ml	> 240 minutes	> 240 minutes
   Epirubicin (Ellence)	2.0 mg/ml	> 240 minutes	> 240 minutes
   Etoposide (Toposar)	20.0 mg/ml	> 240 minutes	> 240 minutes
   Fludarabine	25.0 mg/ml	> 240 minutes	> 240 minutes
   Fluorouracil	50.0 mg/ml	> 240 minutes	> 240 minutes
   Gemcitabine (Gemzar)	38.0 mg/ml	> 240 minutes	> 240 minutes
   Idarubicin	1.0 mg/ml	> 240 minutes	> 240 minutes
   Ifosfamide	50.0 mg/ml	> 240 minutes	> 240 minutes
   Irinotecan	20.0 mg/ml	> 240 minutes	> 240 minutes
   Mechlorethamine HCl	1.0 mg/ml	> 240 minutes	> 240 minutes
   Melphalan	5.0 mg/ml	> 240 minutes	> 240 minutes
   Mesna	50.0 mg/ml	> 240 minutes	> 240 minutes
   Methotrexate	25.0 mg/ml	> 240 minutes	> 240 minutes
   Mitomycin C	0.5 mg/ml	> 240 minutes	> 240 minutes
   Mitoxantrone	2.0 mg/ml	> 240 minutes	> 240 minutes
   Oxaliplatin	2.0 mg/ml	> 240 minutes	> 240 minutes
   Paclitaxel	6.0 mg/ml	> 240 minutes	> 240 minutes
   Paraplatin	10.0 mg/ml	> 240 minutes	> 240 minutes
   Pemetrexed	25.0 mg/ml	> 240 minutes	> 240 minutes
   Pertuzumab	30.0 mg/ml	> 240 minutes	> 240 minutes
   Raltitrexed	0.5 mg/ml	> 240 minutes	> 240 minutes
   Retrovir	10.0 mg/ml	> 240 minutes	> 240 minutes
   Temsirolimus	25.0 mg/ml	> 240 minutes	> 240 minutes
   Thiotepa	10.0 mg/ml	> 240 minutes	> 240 minutes
   Topotecan HCI	1.0 mg/ml	> 240 minutes	> 240 minutes
   Trisenox (Arsenic Trioxide)	1.0 mg/ml	> 240 minutes	> 240 minutes
   Velcade (Bortezomib)	1.0 mg/ml	> 240 minutes	> 240 minutes
   Vinblastine	1.0 mg/ml	> 240 minutes	> 240 minutes
   Vincristine Sulfate	1.0 mg/ml	> 240 minutes	> 240 minutes
   Vinorelbine	10.0 mg/ml	> 240 minutes	> 240 minutes
   Non-Chemotherapy Drug	Concentration	Acceptance Criteria (Implicit)	Reported Device Performance (Breakthrough Detection Time in Minutes)
   Cetuximab	2.0 mg/ml	> 240 minutes	> 240 minutes
   Chloroquine	50.0 mg/ml	> 240 minutes	> 240 minutes
   Cyclosporin A	100.0 mg/ml	> 240 minutes	> 240 minutes
   Cytovene (Ganciclovir)	10.0 mg/ml	> 240 minutes	> 240 minutes
   Fulvestrant	50.0 mg/ml	> 240 minutes	> 240 minutes
   Propofol	10.0 mg/ml	> 240 minutes	> 240 minutes
   Rituximab	10.0 mg/ml	> 240 minutes	> 240 minutes
   Trastuzumab	21.0 mg/ml	> 240 minutes	> 240 minutes
   Triclosan	2.0 mg/ml	> 240 minutes	> 240 minutes
   Zoledronic Acid	0.8 mg/ml	> 240 minutes	> 240 minutes
   Fentanyl Citrate Injection	100mcg/2mL	No breakthrough up to 240 minutes	No breakthrough detected up to 240 minutes
   Gastric Acid	Not specified	No breakthrough up to 240 minutes	No breakthrough detected up to 240 minutes

   Note: For Carmustine, the device did not meet the implied acceptance criteria of >240 minutes, and this is highlighted with a caution and warning in the document ("CAUTION: Testing showed an average breakthrough time of 77.6 minutes with Carmustine. WARNING: Do not use with Carmustine.").

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

   The document does not explicitly state the sample size (e.g., number of gloves tested) for each drug. It states "Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05." ASTM D6978-05 is a standard test method, which would specify the number of specimens to be tested, but this detail is not provided in the FDA letter.

   The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.

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 product is a medical device (examination gloves) that is physically tested for permeation resistance. The "ground truth" is established through laboratory testing according to a recognized standard (ASTM D6978-05), not through expert consensus or interpretation of medical images. Therefore, the concept of "experts" in the context of clinical interpretation/diagnosis is not applicable here. The experts would be the laboratory personnel performing the tests according to the ASTM standard. Their qualifications are not specified but would typically involve training in chemical permeation testing.

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

   Adjudication methods like 2+1 or 3+1 typically refer to reaching a consensus among multiple human readers for diagnostic tasks. This is not applicable to the physical permeation testing of gloves. The results are obtained directly from chemical analysis and measurement equipment according to a standardized protocol, so no human adjudication in that sense is necessary.

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 conducted or is relevant for this type of device (medical examination gloves). This document pertains to the physical performance of gloves, not diagnostic AI software that would involve human readers.

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

   This is not an AI-enabled device or algorithm. It is a physical product (gloves). Therefore, no "standalone" algorithm performance study was done.

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

   The ground truth is established through objective laboratory testing against a recognized standard (ASTM D6978-05), which measures the breakthrough detection time of specific chemicals through the glove material. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

   This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The gloves are physically manufactured and then tested.

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

   As explained above, there is no training set for this type of device.

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Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19. Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

This document is a 510(k) Premarket Notification from the FDA for medical gloves, specifically "Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)". It details the device's technical characteristics, indications for use, and a comparison to a predicate device, along with non-clinical testing results to demonstrate substantial equivalence.

Here's an analysis based on your request, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria and performance data are primarily described in the "NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA" and "BIOCOMPATIBILITY DATA" sections (pages 9-12).

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

The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for permeation, dimensions, etc.) beyond what's implied by the AQL 2.5 for freedom from holes (which dictates the sampling plan based on lot size, but the lot size isn't provided).

• Data Provenance: The studies were non-clinical bench tests and biocompatibility tests performed to established ASTM and ISO standards. The location where these tests were conducted is not specified in this FDA letter, but typically these are performed in certified laboratories. The data is prospective, in the sense that the tests were conducted specifically to demonstrate the performance of the device for this submission.

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

This document describes a 510(k) submission for an examination glove, which is a Class I medical device. The "ground truth" for these tests are established by widely accepted international and national standards (ASTM and ISO). These standards themselves are developed by committees of experts in relevant fields (materials science, chemistry, toxicology, medical device manufacturing, etc.), and the laboratories performing the tests follow strict protocols defined by these standards.

The document does not mention the use of individual human experts (like radiologists for imaging studies) to establish "ground truth" for the performance or safety of the glove itself in the way that would apply to, for example, an AI diagnostic aid. The "ground truth" for the glove's performance is derived directly from the application of the specified physical, chemical, and biological test methods.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and testing. Adjudication methods (like 2+1, 3+1 consensus) are relevant for subjective expert review processes, such as interpreting medical images or clinical outcomes. For the physical and chemical property tests of a glove, the results are quantitative measurements or pass/fail criteria against a defined standard, not subject to human interpretation discrepancies requiring adjudication.

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

No. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) perform tasks with and without AI assistance to measure the AI's impact on human performance. This document pertains to a physical medical device (examination glove), not an AI diagnostic system.

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

Not applicable. This device is a glove, not an algorithm. The performance tests are "standalone" in the sense that they measure the intrinsic properties of the glove itself.

7. The Type of Ground Truth Used

The ground truth for this device is based on defined physical, chemical, and biological performance standards and test methodologies (e.g., ASTM D6319-19 for glove properties, ASTM D6978-05 for chemical permeation resistance, ISO 10993 series for biocompatibility). These standards specify the methods for measuring parameters like tensile strength, freedom from holes, chemical breakthrough time, and biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).

8. The Sample Size for the Training Set

Not applicable. This document is about a physical medical device (glove), not a machine learning or AI model. Therefore, 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 medical device submission.

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Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

Bleomycin Sulfate (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin HCl (2.0 mg/ml)
Epirubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (38.0 mg/ml)
Idarubicin HCl (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)
Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCl (2.0 mg/ml)
Paclitaxel (6.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisenox (1.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes

Warning: Not for Use with: Carmustine, Thiotepa

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) with sizes Medium, Large, X-Large and XX-Large are included in the submission.

The provided text describes the acceptance criteria and performance of the Nephron Nitrile Powder-Free Nitrile Examination Gloves.

Here's the requested information:

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

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

The document does not explicitly state the sample sizes for each test in the level of detail (e.g., number of gloves tested for each specific property or chemotherapy drug). It only refers to compliance with the standards (e.g., AQL 2.5 for freedom from holes).

The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, not human trials or medical imaging data.

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. The document describes bench testing of physical and chemical properties of gloves, not expert interpretation of medical images or clinical data.

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

This information is not applicable. The tests are laboratory-based and follow standardized testing protocols, which do not typically involve adjudication methods like those used for expert review of clinical cases.

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. The document describes the testing of medical examination gloves, which are physical products, not AI systems or medical imaging devices. Therefore, MRMC studies and AI assistance are irrelevant.

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

This information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not algorithms.

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

The "ground truth" for these tests is defined by the technical specifications and performance requirements outlined in the referenced ASTM and ISO standards. For example:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured objectively against defined numerical limits.
• Freedom from holes is assessed against an Acceptable Quality Limit (AQL), a statistical measure.
• Resistance to chemotherapy drugs is measured by detecting breakthrough time using specific analytical methods defined in ASTM D6978.
• Biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) are assessed by observing biological responses in animal models or in vitro systems against established criteria for non-irritancy, non-sensitization, and non-toxicity according to ISO standards.

Essentially, the "ground truth" reflects compliance with regulatory and industry standards for glove performance and safety.

8. The sample size for the training set

This information is not applicable, as this is not a machine learning model.

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

This information is not applicable, as this is not a machine learning model.

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Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.

The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" in comparison to a predicate device. This is a medical device submission, and the information is presented as part of a 510(k) summary to the FDA. As such, the "study" referred to is a series of non-clinical tests performed to demonstrate substantial equivalence, rather than a clinical study involving human patients.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents the acceptance criteria and results mainly in reference to established ASTM and ISO standards for medical gloves. The "Reported Device Performance" column directly reflects the results from the non-clinical tests.

• Width: 70mm (±10mm) - XS, 80mm (±10mm) - S, 95mm (±10mm) - M, 110mm (±10mm) - L, 120mm (±10mm) - XL
• Overall Length: 220 mm (Minimum) – S and XS, 230 mm (Minimum) – M, L and XL
• Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05mm (Minimum) | Pass (met listed dimension requirements) |
  | ASTM D412-16 | Standards test method for Vulcanized Rubber and Thermoplastics Elastomer - Tension | Physical properties:
• Before Aging:
  • Tensile strength: min 14MPa
  • Elongation: min 500%
• After Aging:
  • Tensile strength: min 14MPa
  • Elongation: min 400% | Pass (met listed physical property requirements) |
    | ASTM D5151-19 | Standard Test Method for detection of Holes in Medical Gloves | Pass Inspection Level G1, AQL 2.5 | Pass |
    | ASTM D6124-06 | Standard Test Method for Residual Powder on Medical Gloves | Residual powder meets specification 240 minutes
    Cyclophosphamide (Cytoxan®): > 240 minutes
    Dacarbazine (DTIC): > 240 minutes
    Doxorubicin Hydrochloride: > 240 minutes
    Etoposide (Toposar®): > 240 minutes
    Fluorouracil: > 240 minutes
    Paclitaxel (Taxol®): > 240 minutes
    Thiotepa: 15.0 minutes
    Warning: Do not use with Carmustine and Thiotepa due to low permeation times. |
    | ISO 10993-5 | Biological Evaluation on Medical Devices - Part 5: Test for In Vitro Cytotoxicity | Pass in vitro cytotoxicity | Exhibited "Severe" reactivity at 100% concentration and no cytotoxic effect at 10% concentration. (Note: A systemic toxicity study was performed to address the safety of materials given the cytotoxicity result). |
    | ISO 10993-10 | Biological evaluation on medical device Part 10: Test for Irritation and Skin Sensitization | No irritating and sensitizing | Under the condition of study not an irritant or a sensitizer. |
    | ISO 10993-11 | Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity | No systemic toxic | Under the condition of the test, not a systemic toxicity. |

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

• Sample Size for Test Set: The document does not explicitly state a consolidated sample size for all tests. However, for specific tests, it does provide some details:
  • Freedom from Holes (ASTM D5151-19): AQL = 2.5, Inspection level G1. This standard outlines sampling plans, but the exact number of units tested is not provided in this summary. The predicate device mention "125 samples from batch of 35000", which gives a hint on the sample size used, but this is for the predicate not the subject device.
  • The other non-clinical tests (e.g., physical properties, biocompatibility, chemotherapy permeation) would also have specific sample sizes as per their respective standards, but these are not enumerated in this summary.
• Data Provenance: The document does not explicitly state the country-of-origin for the "data" or whether the tests were retrospective or prospective. Given that this is a 510(k) summary for a device manufactured by "RUBBEREX ALLIANCE SDN BHD" in Malaysia, it is highly probable that the testing was performed in conjunction with the manufacturer or by contract labs. The tests are prospective as they are conducted specifically for the device submission.

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

This section is not applicable as the described "study" consists of non-clinical, laboratory-based tests of physical properties and chemical resistance of gloves against established standards (ASTM, ISO). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes data in this context. The "ground truth" is adherence to the objective criteria defined by the test methods and standards.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving subjective human interpretation (e.g., reviewing medical images) to resolve discrepancies. The tests described here are objective laboratory measurements against defined standards.

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

This section is not applicable. An MRMC study assesses the effectiveness of a diagnostic device or AI with and without human readers. The device in question is a medical glove, for which such a study design is irrelevant.

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

This section is not applicable. "Standalone" performance usually refers to the performance of an AI algorithm without human interaction. This document describes the performance of a physical medical device (gloves) through laboratory tests, not an AI algorithm. The performance described is "standalone" in the sense that it's the intrinsic performance of the glove material.

7. Type of Ground Truth Used:

The "ground truth" for the performance of these gloves is based on:

• Established Standard Specifications: e.g., ASTM D6319-19 for dimensions, tensile strength, elongation.
• Standardized Test Methods and Protocols: e.g., ASTM D5151-19 for holes, ASTM D6124-06 for residual powder, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility.
• The results are quantitative measurements interpreted against pre-defined thresholds or criteria derived from these standards.

8. Sample Size for the Training Set:

This section is not applicable. There is no "training set" as this is not an AI/ML device. The tests performed are to evaluate manufactured products against predefined specifications.

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

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

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

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

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier protection to prevent contamination between a patient and an examiner. The qloves are powder free, ambidextrous, blue color, and beaded cuff.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).

The document describes the acceptance criteria and performance of "Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Permeation Testing Results:

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

• Sample Size: Not explicitly stated in terms of number of gloves tested for each permeation or biocompatibility test. The document refers to compliance with standards like ASTM D6978-05(2019) and ISO 10993, which typically specify sample sizes for such tests.
• Data Provenance: The testing was performed for the submitter, PT. Shamrock Manufacturing Corpora, based in North Sumatera, Indonesia. The tests are "non-clinical tests," implying laboratory-based testing rather than clinical data from human subjects.

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

• This information is not applicable as the document describes non-clinical testing of a medical device (gloves) for physical properties and chemical resistance. There is no "ground truth" established by human experts in the context of diagnostic performance or interpretation. The ground truth for these tests is defined by the standardized methodologies of ASTM and ISO.

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

• This information is not applicable as the document describes non-clinical testing of a medical device (gloves). Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, which are not relevant here.

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. The device is medical examination gloves, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

• This information is not applicable. The device is medical examination gloves, not an algorithm or software. The tests performed are laboratory-based assessments of material properties and chemical resistance.

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

• The "ground truth" for this device's performance is established by standardized test methods and material science principles. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards. For permeation, it's the measured breakthrough time according to ASTM D6978-05(2019). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of device testing for medical gloves. This refers to a dataset used to train AI/machine learning models, which is irrelevant for this device.

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

• This information is not applicable for the same reasons as #8.

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