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Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.

The document describes the acceptance criteria and performance data for the "Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate". This is a medical device, and the evaluation focuses on its physical properties, chemical permeation resistance, and biocompatibility.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Cytotoxicity: The document states the cytotoxicity test "Failed" for the subject device based on the acceptance criteria of "No Cytotoxicity Reaction," as it exhibited severe cytotoxicity at higher concentrations (100% and 66% extract concentrations). However, it notes no cytotoxicity at lower concentrations (44%, 30%, 20%, 15%). The comparison table states "undiluted, 1:2 and 1:4 dilution is cytotoxicity and the dilution 1:8 and 1:16 and 1:32 us non-cytotoxic," and then concludes "Same" when comparing to the predicate device's cytotoxicity results. This implies that this level of cytotoxicity at higher concentrations is considered acceptable within the context of substantial equivalence, despite failing a generic "No Cytotoxicity Reaction" criteria. The device is still cleared, usually meaning the risk is mitigated or assessed as acceptable for the intended use.

Note on Carmustine and ThioTepa: For Carmustine and ThioTepa, the breakthrough times are explicitly stated as "extremely low" and the warning "Do not use with Carmustine and ThioTepa" is included in the Indications for Use and the summary. This indicates these permeation times are not meeting the general acceptance criteria of > 240 minutes for safe use with chemotherapy drugs, and the device is therefore not indicated for 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 sizes (e.g., number of gloves, batches) used for each individual test. It lists the standards followed (e.g., ASTM D6319-10, ASTM D6124-06(2017), ASTM D5151-19, ISO 10993, ASTM D6978-2005). These standards typically define sampling plans, but the specific number of units tested is not reported in this summary.

The data provenance is from non-clinical tests conducted by the manufacturer, Professional Latex Sdn Bhd, located in Malaysia. The tests are reported as demonstrating that the proposed device met all design specifications according to the listed standards.

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

This information is not provided in the document. For medical device performance testing as described (physical, chemical, biocompatibility), "ground truth" is established by the specified test methods in the standards (e.g., ASTM for physical properties and chemical permeation, ISO for biocompatibility). These tests usually involve laboratory analysis and measurements rather than expert consensus on interpretation of, for instance, medical images. The results are objective measurements against predefined criteria.

4. Adjudication method for the test set

This is not applicable as the tests are primarily objective measurements against established standard criteria, not subjective interpretations requiring adjudication by experts.

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 document pertains to the safety and performance testing of a physical medical device (examination gloves), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

Not applicable. This document is not about an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the acceptance criteria is based on:

• Standardized Test Methods and Specifications: For physical properties (e.g., length, thickness, tensile strength, elongation, powder content, freedom from holes), the ground truth is defined by the requirements of international and national standards such as ASTM D6319-10, ASTM D6124-06(2017), and ASTM D5151-19.
• Permeation Resistance Measurement: For chemotherapy drugs and fentanyl citrate, the ground truth is the measured breakthrough detection time according to ASTM D6978-2005.
• Biocompatibility Standards: For irritation, sensitization, cytotoxicity, and acute systemic toxicity, the ground truth is determined by the Pass/Fail criteria defined within ISO 10993 standards (ISO 10993-10, ISO 10993-5, ISO 10993-11).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for physical product validation.

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

Not applicable. (See 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 patient and examiner

Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

This document is a 510(k) premarket notification for a medical device: "Powder Free Latex Examination Glove." It's not a study proving an AI/computer-aided device meets acceptance criteria, but rather a regulatory submission demonstrating substantial equivalence to a predicate device based on non-clinical performance data for a physical product (a glove).

Therefore, I cannot extract the information required to populate a table for acceptance criteria of an AI device, nor provide details about a study that proves an AI device meets acceptance criteria. The document does not describe:

• AI device performance metrics: The criteria and results are for physical glove characteristics (e.g., tensile strength, freedom of holes, dimensions).
• Sample size for test set or data provenance for an AI algorithm.
• Number of experts and their qualifications for establishing ground truth related to AI.
• Adjudication method for AI ground truth.
• MRMC study or effect size of AI assistance on human readers.
• Standalone AI performance.
• Type of ground truth (e.g., pathology, outcomes data) for medical images.
• Training set size or ground truth establishment for an AI model.

The document states:

• "8.0 Assessment of Clinical Performance Data: Not applicable - Clinical data is not needed." This further indicates the absence of a study similar to what would be done for an AI/CADe device.
• "7.0 Non-Clinical Performance Data: The performance test data of the non-clinical tests is reported in the table above." This refers to the physical and chemical properties of the glove.

In summary, this document is entirely unrelated to the type of AI/CADe device evaluation you're asking about. It's a regulatory submission for a simple Class I physical medical device (examination gloves).

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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 patient and examiner

Non-Sterile, Powder Free Nitrile Examination Gloves - Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for overthe counter single use.

The provided document is a 510(k) premarket notification for a medical device: "Powder Free Nitrile Examination Glove". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials or a specific study designed to meet detailed acceptance criteria typical of novel AI/ML devices. Therefore, the questions related to AI/ML device studies (such as MRMC studies, ground truth establishment for AI training/test sets, effect sizes of AI assistance, and number of experts for ground truth) are not applicable to this document.

For this conventional medical device, the "acceptance criteria" are essentially the performance standards outlined in ASTM Specification D6319-10 and other relevant tests for patient examination gloves. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted by the manufacturer.

Here's an interpretation of the document in the context of the requested information, noting the inapplicable fields:

Acceptance Criteria and Device Performance for Powder Free Nitrile Examination Glove (K171667)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on ASTM Specification D6319-10. The performance data for the subject device (K171667) is compared to these ASTM standards (or implied standards based on the predicate device's specifications).

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for Freedom of Holes, tensile strength, etc.). However, it indicates that the tests conform to ASTM standards (e.g., ASTM Specification D6319-10), which would prescribe appropriate sample sizes for such physical and chemical tests.

• Data Provenance: The manufacturer, Professional Latex Sdn Bhd, is based in Malaysia ("Kamunting, Perak"). The testing would have been conducted by or for the manufacturer. The data is retrospective in the sense that the tests were performed and results collected before the 510(k) submission.

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

This question is not applicable as this is a physical medical device (examination gloves), not an AI/ML diagnostic or image analysis device that requires expert human interpretation for "ground truth". The "ground truth" for these tests are the objective measurements (e.g., tensile strength, dimensions, water leak test results).

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert review processes for subjective assessments (e.g., image interpretation), which is not relevant for the objective physical and chemical tests of gloves.

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 question is not applicable. This is not an AI/ML device, and no MRMC study was performed.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective physical, chemical, and biological test measurements as per recognized standards (e.g., ASTM D6319-10). Examples include:

• Physical measurements: Length, width, thickness (using calipers/micrometers).
• Mechanical properties: Tensile strength, ultimate elongation (using a universal testing machine).
• Barrier integrity: Freedom of holes (water leak test, AQL).
• Chemical analysis: Residual powder (gravimetric analysis).
• Biocompatibility: Primary skin irritation, dermal sensitization (in vivo animal or in vitro tests).

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/ML device, so there is no "training set." The glove manufacturing process involves quality control and testing of product batches.

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

This question is not applicable. As there is no "training set" in the AI/ML sense, this process is irrelevant for this device.

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