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

Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives.

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 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.

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim

This document is an FDA 510(k) clearance letter for "Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim." It primarily focuses on the substantial equivalence determination for this medical device and its performance against specific chemical permeation tests.

Given the nature of the document, which pertains to a physical medical device (gloves) and not an AI/ML-driven device or diagnostic tool, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable.

The "acceptance criteria" and "study" described in the document relate to the gloves' physical and chemical barrier properties, specifically:

• Low Dermatitis Potential: Demonstrated reduced potential for sensitizing users to chemical additives. (The document doesn't detail the specific study methodology for this, but it implies a test was conducted.)
• Chemotherapy Drug Permeation Resistance: Tested for permeation using ASTM D6978-05.
• Fentanyl Permeation Resistance: Tested for permeation using ASTM D6978-05.

Here's how the provided information fits the closest possible interpretation of your request for this type of device:

Acceptance Criteria and Device Performance (for physical/chemical properties):

Regarding the specific questions tailored for AI/ML or diagnostic performance studies:

• Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to chemical permeation tests on glove samples, not patient data for an AI algorithm. The provenance would be the gloves themselves and the chemicals used in the ASTM D6978-05 standard.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. "Ground truth" for this device is established by chemical analysis according to a standardized protocol (ASTM D6978-05), not by human expert opinion on images or clinical cases.
• Adjudication method: Not applicable. Chemical tests follow a protocol, not an adjudication process.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks.
• If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
• The type of ground truth used: For chemical resistance, the ground truth is the quantitative measurement of breakthrough time according to a standardized chemical test (ASTM D6978-05). For low dermatitis, it would be results from a dermatological irritation/sensitization test.
• The sample size for the training set: Not applicable. There is no AI model being trained.
• How the ground truth for the training set was established: Not applicable.

In summary, this FDA document is for a conventional Class I medical device (nitrile examination gloves) and its clearance is based on laboratory testing of its physical and chemical properties, not on AI/ML performance or diagnostic accuracy studies.

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Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs 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 using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.

The provided text describes testing and acceptance criteria for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942), focusing on their resistance to chemotherapy drug permeation. This is a medical device, not an AI/ML-based diagnostic or prognostic tool, therefore, many of the typical questions regarding AI model evaluation (like sample size for training set, number of experts for ground truth, MRMC studies, etc.) are not applicable to this submission.

The study proves the device's substantial equivalence to a predicate device (K172525) and its performance according to established industry standards.

Here's an analysis of the acceptance criteria and the study performance for the chemotherapy drug permeation aspect, as that's where specific performance data is provided:

Acceptance Criteria and Reported Device Performance

The key performance criterion for these gloves regarding chemotherapy drugs is the "Minimum Breakthrough Detection Time" as per ASTM D6978-05. While specific "acceptance criteria" (e.g., "must be >X minutes") are not explicitly stated as numerical thresholds for all drugs, the implicit acceptance criterion is to demonstrate a breakthrough time for each tested chemotherapy drug, and for certain drugs, specifically those known to have low permeation times (Carmustine and Thiotepa), to explicitly state their observed values, even if low. For the majority of drugs, the goal is often to demonstrate a breakthrough time exceeding a common testing duration (e.g., >240 minutes, which is 4 hours).

Table of Acceptance Criteria (Implicit) and Reported Device Performance:

The manufacturer clearly states the two drugs with "extremely low permeation times" (Carmustine and Thiotepa), indicating transparency and adherence to relevant standards (ASTM D6978-05).

Study Details:

This submission is for a medical device (gloves), not an AI/ML diagnostic. Therefore, the following points typical for AI/ML device evaluations are not applicable (N/A):

1. Sample Size used for the Test Set and the Data Provenance:

   • Test Set Sample Size: The document does not specify a "sample size" in terms of number of gloves tested for each drug, but rather the performance against a list of chemicals. ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) outlines the methodology for such testing. Typically, this would involve a statistically significant number of specimens to ensure reproducibility and reliability, but the exact number isn't in this summary.
   • Data Provenance: The testing was done on the "Proposed Device" manufactured by Central Medicare Sdn. Bhd., located in Teluk Intan, Perak, Malaysia. The data is prospective, a result of new testing on the device.

2. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts: N/A for this type of device. The "ground truth" is established by physical/chemical testing as per recognized ASTM standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Physical/chemical testing does not involve human adjudication in this context.

4. 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: N/A. This is not an AI/ML device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical product, not an algorithm.

6. The type of ground truth used:

   • The ground truth for chemotherapy drug permeation is established through laboratory testing using standardized methods (ASTM D6978-05), which measures the time it takes for a chemical to permeate through a material. This is an objective, quantitative measurement, not based on expert consensus, pathology, or outcomes data in the traditional medical sense.
   • Other ground truths for the gloves' properties (tensile strength, elongation, freedom from holes, powder content) are established via their respective ASTM standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6124-06).

7. The sample size for the training set: N/A. This is not an AI/ML device.

8. How the ground truth for the training set was established: N/A. This is not an AI/ML device.

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Orange Non Sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Orange Non Sterile Powder Free Nitrile Examination are Class I Patient Examination Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and follows the FDA Medical Glove Guidance Manual.

This document describes the acceptance criteria and the study proving that "Orange Non Sterile Powder Free Nitrile Examination Gloves" meets these criteria.

Acceptance Criteria and Reported Device Performance

The device, "Orange Non Sterile Powder Free Nitrile Examination Gloves," demonstrates substantial equivalence to its predicate device (K143247) by meeting the following acceptance criteria based on established ASTM standards and FDA guidance:

Study Details

The provided document describes a non-clinical performance study to demonstrate substantial equivalence, rather than a traditional medical device clinical trial with a test set of data and ground truth established by experts.

1. Sample size used for the test set and the data provenance: Information regarding the specific sample sizes for tests such as tensile strength, elongation, freedom from holes, and powder content is not explicitly stated in this summary. The tests were performed in accordance with ASTM standards, which would specify appropriate sample sizes. The data provenance is internal testing conducted by the manufacturer, Central Medicare Sdn. Bhd., in Malaysia.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the evaluation is based on objective measurements against engineering and material standards (ASTM, ISO) rather than expert interpretation of medical images or patient outcomes. The "ground truth" is defined by these established industry standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable as the evaluation relies on direct physical and chemical measurements rather than subjective assessment requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is an examination glove, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is based on established industry standards and test methods, specifically:

   • ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
   • ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves
   • ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves
   • ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection
   • ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
   • ASTM D412-16: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
   • ASTM D7160-16: Standard Practice for Determination of Expiration Dating for Medical Gloves
   • ASTM D573-04: Standard Test Method for Rubber—Deterioration in an Air Oven
   • 16 CFR 1500.41: Method of testing primary irritant substances
   • FDA Medical Glove Guidance Manual (Document issued on January 22, 2008)

7. The sample size for the training set: This is not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established: This is not applicable for the same reason as above.

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Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs 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 using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large.

Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.

This document describes the premarket notification for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs" (K172525). The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device (K163146) based on technological characteristics and performance data, particularly regarding resistance to chemotherapy drug permeation.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to ASTM standards and comparative performance against the predicate device.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for permeation, holes, or physical properties). However, it implies that the testing was conducted "in accordance with ASTM D5151-06, following ASTM D6319 AQL 2.5/Inspection Level G-I" for freedom from holes, which dictates sample size based on lot size and AQL. For other tests like chemotherapy drug permeation (ASTM D6978-05), the standard itself would define the testing methodology and implied sample size per drug.
• Data Provenance: The manufacturer, Central Medicare Sdn. Bhd., is located in Teluk Intan, Perak, Malaysia. The tests were likely conducted in Malaysia or by a testing facility in adherence to the specified ASTM standards. The data is retrospective in the sense that it represents characterization of the manufactured gloves to support the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

This device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for glove performance is established through standardized physical and chemical tests (e.g., ASTM D6319-10, ASTM D6978-05). The "experts" are the qualified laboratory personnel performing these tests according to the standard operating procedures of the testing facilities. Their qualifications typically involve training and certification in laboratory testing methodologies relevant to material science and medical device performance standards.

4. Adjudication Method for Test Set

Not applicable for this type of device and testing. Test results are objective measurements from standardized protocols rather than subjective interpretations requiring adjudication.

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

Not applicable. This is a physical medical device (examination glove), not an imaging or diagnostic AI system.

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

Not applicable. This is a physical medical device. The performance evaluated is the physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The ground truth used is based on:

• Performance Standards: Adherence to established industry standards such as ASTM D6319-10 (for general glove properties) and ASTM D6978-05 (for chemotherapy drug permeation).
• Objective Laboratory Measurements: Direct measurements of tensile strength, elongation, freedom from holes, powder content, and breakthrough times for chemotherapy drugs. These are quantifiable results obtained through controlled experimental procedures.
• Biocompatibility Studies: In vitro or in vivo tests to assess sensitization and irritation, which also yield objective results based on established protocols.

8. Sample Size for Training Set

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

9. How Ground Truth for Training Set Was Established

Not applicable, as no training set is relevant for this device.

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