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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 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs

The provided document describes the FDA clearance for "Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs" (K220155). This is a medical device, specifically examination gloves, and not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, are not applicable to this submission.

However, the document does contain information about the acceptance criteria and the study that proves the device meets those criteria for its intended use with chemotherapy drugs.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "WARNING: Not recommended for use with Carmustine and ThioTepa" due to their low permeation times. This indicates that while the testing was performed, the acceptance criteria for these specific drugs effectively resulted in a caveat for their use, highlighting that the "accepted" performance for other drugs is >240 minutes.

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

The document does not specify the sample size used for the test set (number of gloves or repetitions of testing). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in the full study report, which is not included in this FDA clearance letter.

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

Not applicable. This is a physical device (gloves) and its performance against chemical permeation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation. The "ground truth" is the chemical permeation itself, measured objectively.

4. Adjudication method for the test set

Not applicable. As this is not an AI/ML device, there's no "adjudication" in the sense of reconciling expert opinions on diagnoses or interpretations. The permeation testing follows a standardized protocol (ASTM D6978-05).

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance regarding chemotherapy drug permeation is established through objective laboratory testing following a recognized standard. Specifically, it used ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This standard defines the methodology to measure the breakthrough time of various chemotherapy drugs through the glove material.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of an algorithm.

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

Not applicable. As this is not an AI/ML device, there is no training set.

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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, Simulated Gastric Acid, and Fentanyl Citrate.

The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand.

The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).

This document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves. The "device" in question is medical examination gloves, not an AI/ML powered medical device, therefore many of the requested criteria (e.g., number of experts, MRMC studies, training/test set ground truth establishment) are not applicable.

However, I can extract information related to acceptance criteria and performance as presented in the document for the glove device.

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

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions sample sizes indirectly through "Inspection Level G-1" and "AQL 2.5" which are statistical sampling plans. For instance, for freedom from holes, it states: "XS/XXL – 0/160; S/M/XL – 1/250; L – 2/250", which implies a sample size of 160 or 250 units depending on the glove size, with an allowable number of non-conforming units (holes) of 0, 1, or 2.

The data provenance is not explicitly stated as "country of origin of the data" or "retrospective/prospective." However, the submitter's address is "PT. MAJA AGUNG LATEXINDO Jl. Utama No. 98, Pujimulyo, Sunggal 20352 Deli Serdang North Sumatera - Indonesia," suggesting the testing was conducted in Indonesia or by a lab associated with the manufacturer. The testing methods refer to ASTM standards, which are internationally recognized. This is pre-market testing, so it's inherently prospective data for the regulatory submission.

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

Not applicable. This device is a physical product (medical gloves) and not an AI/ML medical device. "Ground truth" in this context refers to measurements against established physical and chemical standards, not expert interpretations of medical images or data.

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

Not applicable. This is not an image-based or clinical data-based study requiring adjudication. The results are objective measurements from laboratory tests.

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

Not applicable. No AI/ML component in this medical device.

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

Not applicable. No algorithm component in this medical device.

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

The "ground truth" for this device is based on established, objective, and quantifiable performance criteria defined by recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for medical gloves. This includes:

• Physical dimensions
• Physical properties (tensile strength, elongation)
• Freedom from pinholes (measured by water leak test)
• Residual powder content
• Permeation resistance to specific chemicals (measured as breakthrough time)
• Biocompatibility (in vitro/in vivo tests for irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set:

Not applicable. No training set is used as this is not an AI/ML device. The testing described pertains to product validation and verification against established performance standards.

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

Not applicable. No training set is used. The "ground truth" for the performance metrics is established by the test methods outlined in the aforementioned ASTM and ISO standards. These standards prescribe the procedures and criteria for evaluating the glove's performance.

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

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.

The following drugs and concentrations have been tested the minimum breakthrough result of >240 minutes: Arsenic Trioxide 1.0 Azacitidine (Vidaza) 25.0 Bendamustine HCl 5.0 Bleomycin Sulfate 15.0 Busulfan 6.0 Carboplatin 10.0 Carfilzomib 2.0 Cetuximab 2.0 Chloroquine 50.0 Cisplatin 1.0 Cladribine 1.0 Cyclophosphamide (Cytoxan) 20.0 Cyclosporin A 100.0 Cytarabine 100.0 Cytovene (Ganciclovir) 10.0 Dacarbazine 10.0 Daunorubicin 5.0 Decitibine 5.0 Docetaxel 10.0 Doxorubicin Hydrochloride 2.0 Epirubicin (Ellence) 2.0 Etoposide (Toposar) 20.0 Fludarabine 25.0 Fluorouracil 50.0 Fulvestrant 50.0 Gemcitabine (Gemzar) 38.0 Idarubicin 1.0 Ifosfamide 50.0 Irinotecan 20.0 Mechlorethamine HCl 1.0 Melphalan 5.0 Mesna 50.0 Methotrexate 25.0 Mitomycin C 0.5 Mitoxantrone 2.0 Oxaliplatin 2.0 Paclitaxel 6.0 Paraplatin 10.0 Pemetrexed 25.0 Pertuzumab 30.0 Propofol 10.0 Raltitrexed 0.5 Retrovir 10.0 Rituximab 10.0 Temsirolimus 25.0 Topotecan HCl 1.0 Trastuzumab 21.0 Triclosan 2.0 Trisenox (Arsenic Trioxide) 1.0 Velcade (Bortezomib) 1.0 Vinblastine 1.0 Vincristine Sulfate 1.0 Vinorelbine 10.0 Zoledronic Acid 0.8

The following drugs have permeation times lower than 240 minutes: Carnustine: 55.1 minutes and Thiotepa: 199.2 minutes.

Fentaryl Permeation Resistance Claim - 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 Claim - 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 Fentaryl 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) clearance letter for Blue Non Sterile Powder Free Nitrile Examination Gloves. It details the device's intended use and claims about its resistance to chemotherapy drugs, gastric acid, and fentanyl permeation. It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/machine learning device.

The questions in the prompt are specific to the performance evaluation of an AI/machine learning-based medical device. This document describes the device performance claims for a physical medical device (gloves) based on physical permeation testing against various chemical agents, not an AI algorithm.

Therefore, I cannot provide answers to the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance: While drug permeation times are listed, these are performance metrics for a physical glove, not an AI device. There are no "acceptance criteria" in the AI sense (e.g., target precision, recall, AUC).
2. Sample size for test set and data provenance: Not applicable to a physical glove's chemical resistance testing.
3. Number of experts for ground truth and qualifications: Not applicable; ground truth for chemical resistance is determined by laboratory measurements, not expert consensus.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for human reader performance with/without AI assistance.
6. Standalone (algorithm only) performance: Not applicable; there is no algorithm.
7. Type of ground truth used: For these gloves, the "ground truth" is laboratory measurement of chemical permeation according to ASTM D6978-05.
8. Sample size for the training set: Not applicable; there's no training set for an AI algorithm.
9. How ground truth for the training set was established: Not applicable.

The document describes the testing methodology for the gloves' chemical resistance, which is analogous to how device performance is evaluated, but it's for a physical product, not an AI system. Specifically:

• Acceptance Criteria/Performance: The device "acceptably" resists permeation by various chemotherapy drugs, gastric acid, and fentanyl.
  • For most listed chemotherapy drugs, the minimum breakthrough result was ">240 minutes" when tested according to ASTM D6978-05.
  • For BCNU (Carmustine) and Thiotepa, permeation times were lower (55.1 minutes and 199.2 minutes, respectively).
  • For Fentanyl Citrate Injection and Gastric Acid, no breakthrough was detected up to 240 minutes.
• Study Proving Acceptance: The device was tested for use with chemotherapy drugs, gastric acid, and fentanyl permeation resistance claims using ASTM D6978-05. This standard dictates the testing methodology for assessing the resistance of medical gloves to permeation by chemotherapy drugs. The results obtained from this standard testing are what "prove" the device meets its claims.

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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.

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.

Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >>240 mins
Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HC1 5.0 mg/ml >>240 mins Bleomycin Sulfate 15.0 mg/ml >>240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml >>240 mins Chloroquine 50.0 mg/ml >>240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml >>240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml >> 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml >>240 mins Decitibine 5.0 mg/ml >>240 mins Docetaxel 10.0 mg/ml >>240 mins Doxorubicin Hydrochloride 2.0 mg/ml >>240 mins Epirubicin (Ellence) 2.0 mg/ml >> 240 mins Etoposide (Toposar) 20.0 mg/ml >>240 mins Fludarabine 25.0 mg/ml >>240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml >> 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml >>240 mins Irinotecan 20.0 mg/ml >>240 mins Mechlorethamine HCl 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml >>240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml >>240 mins Mitomycin C 0.5 mg/ml >>240 mins
Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml >>240 mins Paraplatin 10.0 mg/ml >>240 mins Pemetrexed 25.0 mg/ml >>240 mins Pertuzumab 30.0 mg/ml >>240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml >>240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCl 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml >>240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml >> 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml >>240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml >>240 mins Zoledronic Acid 0.8 mg/ml > 240 mins

CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine.

WARNING: Do not use with Carmustine and Thiotepa.

Fentanyl Permeation Resistance Claim - 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 Claim - 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.

The provided document is a 510(k) premarket notification letter from the FDA for examination gloves. It does not describe an AI/ML powered medical device, nor does it contain information about acceptance criteria, study data, ground truth, or other aspects related to the evaluation of such devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from this document. The questions about AI/ML device performance, human readers, training/test sets, and ground truth are not applicable to the content provided.

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