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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. This glove has been tested for use with specific chemotherapy drugs listed below.

Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim, meets all of the requirements of ASTM D 6319-10.

This document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile, with Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim. The submission seeks to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Low Dermatitis Potential (Modified Draize-95 Test):
  • Sample Size: A total of 200 human subjects.
  • Data Provenance: Prospective, clinical study. The document states, "The study was conducted in two stages. In the first stage, a population of 50 human subjects was tested... The second stage was initiated on a further number of subjects to a total of a minimum of 200 individuals after the first stage..."
  • Country of Origin: Not explicitly stated, though the submitter is based in Malaysia. The study aimed to reflect "the general user population in the US."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the Modified Draize-95 Test or the Chemotherapy Drugs Permeation Test. These tests are standardized laboratory and human subject tests, respectively, where the "ground truth" is determined by the specific criteria and readings of the test methods rather than expert consensus on subjective findings.

4. Adjudication method for the test set

The document does not describe an adjudication method for the tests performed. For the human subject testing (Modified Draize-95), the results were simply "all negative," indicating no ambiguous findings requiring adjudication. For the other performance tests (e.g., dimensions, physical properties, pinholes, powder residue, chemotherapy permeation), the results are quantitative or pass/fail against established 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a medical glove, and the nature of its evaluation does not involve human readers interpreting data or AI assistance.

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

This is not applicable as the device is a medical glove, not an algorithm or AI system.

7. The type of ground truth used

• For physical properties, pinholes, and powder free residue: Ground truth was established by adherence to recognized ASTM (American Society for Testing and Materials) standards (ASTM D6319-10, ASTM D5151-11, ASTM D6124-11), which define objective test methods and acceptance criteria.
• For biocompatibility (dermal sensitization and primary skin irritation): Ground truth was established by adherence to ISO 10993-10:2010 and 16 CFR Part 1500.41, which are standardized testing protocols for biological evaluation of medical devices.
• For Low Dermatitis Potential: Ground truth was established through a human clinical study (Modified Draize-95 Test) observing the absence of allergic or irritant reactions in human subjects.
• For Chemotherapy Drugs Permeation Test: Ground truth was established by adherence to the ASTM D6978-05 standard, which outlines specific methods for measuring drug permeation through protective materials.

8. The sample size for the training set

This is not applicable as the device is a medical glove and does not involve machine learning or AI models with training sets.

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

This is not applicable as the device is a medical glove and does not involve machine learning or AI models with training sets.

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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.

Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim, meets all of the requirements of ASTM D 6319-10.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: 200 non-sensitized adult human subjects.
   • Data Provenance: The document states the study subjects "reasonably reflect the general user population in the US," implying the study was conducted with a US-representative population, making it prospective in nature for the purpose of this assessment.

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

   • The document does not specify the number of experts or their qualifications for establishing ground truth in the Modified Draize-95 Test. It only mentions that the study was "conducted" and "gave all negative results," indicating a clinical assessment.

3. Adjudication method for the test set:

   • The document does not explicitly state an adjudication method (like 2+1 or 3+1). The "Modified Draize-95 Test" involves clinical observation and assessment.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a patient examination glove, and the studies performed are related to its physical and biological properties in humans, not diagnostic reading by human experts with or without AI assistance.

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

   • Yes, the performance of the device itself was evaluated in a standalone manner against established standards and through clinical testing. The Modified Draize-95 Test assessed the glove's potential to cause irritation or sensitization directly, without human "reading" of an output or an AI algorithm.

6. The type of ground truth used:

   • For the "Low Dermatitis Potential" claim, the ground truth was clinical outcomes data from human subjects (i.e., observation of skin reactions like irritation or sensitization).
   • For other characteristics (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Biocompatibility), the ground truth was based on adherence to quantitative and qualitative standards defined by ASTM and ISO.

7. The sample size for the training set:

   • This is not applicable as the studies described are for verification and validation of a physical medical device (examination gloves), not for training an AI model.

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

   • Not applicable, as there is no AI model or training set mentioned for this device.

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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.

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile, meets all of the requirements of ASTM D 6319-10.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non-Colored). Non-Sterile" device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Biocompatibility). It only states that the device "meets" the referenced ASTM and ISO standards. These standards themselves would define the required sample sizes for their respective tests.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that Kossan Latex Industries is a Malaysian company and they are claiming compliance with international standards, it's highly probable the testing was conducted by or overseen by the manufacturer, potentially in Malaysia or by certified testing labs. The document implies these are prospective tests conducted to demonstrate compliance for the 510(k) submission.

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

This type of information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against objective, measurable, and standardized technical specifications (ASTM, ISO, CFR standards). Ground truth, in the sense of expert consensus, is typically relevant for interpretative tasks, such as diagnostic imaging analysis or clinical assessments, which is not the case for this product.

4. Adjudication Method for the Test Set

This is not applicable. The performance evaluations are based on direct measurement and laboratory testing against pre-defined, quantitative standards, not on subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This submission is for a physical medical device (patient examination glove), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.

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

This is not applicable for the same reasons as point 5. There is no algorithm involved with this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is the objective measurement and testing results against the established quantitative criteria defined in the referenced standards (ASTM D 6319-10, ASTM D 5151-06, ASTM D 6124-06, ISO 10993-10:2010, and 16 CFR Part 1500). For example:

• Dimensions: Measured directly against the specified ranges in ASTM D 6319-10.
• Physical Properties: Tensile strength, elongation, etc., measured according to methods outlined in ASTM D 6319-10.
• Freedom from pin-holes: Water leak test (ASTM D 5151-06) or air leak test methods.
• Powder Free Residue: Measured gravimetrically as per ASTM D 6124-06.
• Biocompatibility: Standardized biological assays (dermal sensitization, primary skin irritation) with predefined endpoints for "not a sensitizer" or "not an irritant."

8. The Sample Size for the Training Set

This is not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI. Performance is based on physical testing of manufactured samples.

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

This is not applicable for the same reasons 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 or finger to prevent contamination between pariesoo and examiner. This device is not intended to be used as a chemical barrier.

Powder-free Nitrile Patient Examination Glove, White (non-colored) and Blue Colored, Tested for use with Chemotherapy Drugs

This document is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Tested for use with Chemotherapy Drugs.

The letter states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, or expert qualifications).

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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