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Powdered Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are green in color and are powdered.

The provided document is a 510(k) summary for "POWDERED GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". This type of device (examination gloves) is a well-established medical product, and its evaluation for regulatory clearance focuses on material properties, performance characteristics (like puncture resistance, tensile strength, and freedom from holes), and biocompatibility, rather than sophisticated signal processing or AI algorithms.

Therefore, many of the typical questions asked for AI/ML-driven medical devices, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone algorithm performance," "training set size," or "number of experts for ground truth," are not applicable to this submission. The device is a physical product, not a software algorithm.

Here's a breakdown of the requested information based on the provided text, with clarifications where questions do not apply:

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

The device is evaluated against the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The 510(k) summary explicitly states: "Gloves meet all the current ASTM D 6319-00a." and "MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a".

While the specific numerical acceptance criteria from ASTM D 6319-00a are not fully detailed in this 510(k) summary, the document indicates full compliance. ASTM D 6319-00a generally covers criteria such as:

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

• Sample Size: The document does not specify the exact sample sizes used for each test within the ASTM D 6319-00a standard. ASTM standards typically define sampling plans (e.g., AQL levels for visual and physical defects), but the specific number of gloves tested is not in this summary.
• Data Provenance: The device manufacturer (Latexx Manufacturing Sdn. Bhd.) is located in Malaysia. The testing was performed according to ASTM D 6319-00a and 21 CFR 800.20 requirements. The details on where the tests were executed (e.g., specific lab location) are not provided. The nature of these tests (e.g., physical property measurements, biocompatibility) is prospective in the sense that they are performed on manufactured product batches to ensure compliance.

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 question is not applicable. The "ground truth" for examination gloves is established by objective physical and chemical testing (e.g., tensile strength machines, water leak tests, chemical analysis, animal biocompatibility studies), not by human expert interpretation in the same way as medical imaging or clinical diagnostic data.

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

This question is not applicable. Adjudication methods are typically used for subjective clinical assessments or interpretations where multiple observers might disagree. The tests for examination gloves are objective, laboratory-based measurements.

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 device is an examination glove, not an AI software. Therefore, no MRMC study or AI assistance evaluation 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 a physical product, not an algorithm.

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

The ground truth is established through:

• Standardized physical and mechanical property testing: Per ASTM D 6319-00a (e.g., measurements for tensile strength, elongation, dimensions, leak tests).
• Biocompatibility testing: Conducted using animal models for primary skin irritation (rabbit) and delayed contact sensitization (guinea pig). These are laboratory-derived ground truths based on standardized biological assay results.

8. The sample size for the training set

This question is not applicable. This device does not involve machine learning or a "training set."

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

This question is not applicable. There is no machine learning "training set" for this device.

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Blue Colour Powder Free Nitrile Rubber Examination Gloves is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6913-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are blue in color and are powder free.

The provided document describes the acceptance criteria and the study conducted for the Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Gloves.

Here's the breakdown:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves" and "Non-clinical laboratory and animal based test data indicate that the powder-free product meets all performance and biocompatibility requirements." However, specific numerical values for physical properties (e.g., tensile strength, elongation, force at break, freedom from holes) are not provided in this summary.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for each specific test within ASTM D 6319-00a. However, it indicates testing was performed per ASTM D 6319-00a. This standard specifies sampling plans for various tests (e.g., visual inspection for defects, physical dimensions, physical properties, leak test).
• Data Provenance:
  • Country of Origin: The test origin is not explicitly stated, but the submitter (Latexx Manufacturing Sdn. Bhd.) is based in Malaysia.
  • Retrospective or Prospective: The testing described for this 510(k) is prospective, as it was conducted to demonstrate substantial equivalence for the new device 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)

This is not applicable to the evaluation of examination gloves. The "ground truth" for examination gloves is established through adherence to recognized international standards (ASTM D 6319-00a) for physical properties and validated laboratory test methods for biocompatibility and chemical composition. There are no human "experts" in the sense of medical diagnosticians establishing interpretations.

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

This is not applicable. The assessment involves physical, chemical, and biological testing against predefined scientific criteria, not subjective human interpretation 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. The device is a medical glove, not an AI-assisted diagnostic tool.

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

This is not applicable. The phrase "standalone performance" typically refers to the performance of an AI algorithm. This device is a physical product (medical glove) and its performance is evaluated through laboratory and preclinical (animal) tests, not algorithmic output.

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

The "ground truth" for the device's performance is established by:

• Accredited laboratory testing and adherence to published, universally accepted industry standards: Specifically, ASTM D 6319-00a for Nitrile Examination Gloves. This standard dictates test methods and acceptable limits for properties like dimensions, physical characteristics (tensile strength, elongation), and freedom from holes.
• Established biological testing protocols: For biocompatibility (primary skin irritation and delayed contact sensitization), validated animal models are used as the ground truth.
• Standardized chemical tests: For powder-free claims, a USP iodine test for starch is used.

8. The sample size for the training set

This is not applicable. The device is a manufactured product, not an AI model that requires a training set.

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

This is not applicable, as there is no training set for this device.

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Powder Free Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Medtexx™ Powder Free Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are natural white in color and are powder free.

The provided document is a 510(k) summary for "POWDER FREE GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". It describes the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the document. The statement "Testing performed per ASTM D 6319 - 00a" implies that appropriate sample sizes as dictated by the standard were used, but the specific numbers are not mentioned.
• Data Provenance: The document states "Testing performed per ASTM D 6319 - 00a" and refers to "laboratory and animal based test data." This indicates the tests were conducted in a controlled environment (laboratory) and involved animal subjects (rabbits and guinea pigs), likely conducted by the manufacturer or a contracted lab. The country of origin of the data is not explicitly stated, but the manufacturer is based in Malaysia. These were non-clinical (pre-market) tests, which are typically prospective in nature for a new device submission.

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" for examination gloves is established by objective engineering and biocompatibility standards (ASTM D 6319-00a and 21 CFR 800.20), not by expert consensus in interpreting images or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human interpretation of medical data is being evaluated, typically for diagnostic devices. For examination gloves, performance is measured against objective 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:

This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is an examination glove, which does not involve human interpretation or AI assistance in its function.

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

This information is not applicable. "Standalone" performance generally refers to the performance of an AI algorithm independent of human interaction. Since this device is an examination glove, it does not involve any algorithms.

7. The type of ground truth used:

• The ground truth used is based on established industry standards and regulatory requirements.
  • ASTM Specification D 6319-00a: This standard defines the physical requirements (e.g., dimensions, tensile strength, elongation, freedom from holes) for nitrile examination gloves. The device's performance against these specifications serves as the factual "ground truth" for its physical properties.
  • 21 CFR 800.20: This refers to the FDA's biocompatibility requirements for medical devices. The results from primary skin irritation and delayed contact sensitization tests against these requirements form the biocompatibility "ground truth."
  • USP iodine test: Used to confirm the absence of starch, which is the "ground truth" for being "powder-free."

8. The sample size for the training set:

This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product (examination glove) and does not involve machine learning or AI.

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

This information is not applicable, as there is no training set for this device.

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Medtexx Powder free Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

MEDTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 95, Standard Specification for Rubber Examination Gloves. They are natural white in color and are powder free.

Here's an analysis of the provided information regarding the MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES, focusing on acceptance criteria and supporting studies:

Assessment of the Provided Information:

The provided document describes a 510(k) premarket notification for a medical device: "MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES". This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.

It's crucial to understand that this document describes a physical medical device (gloves), not an AI/software as a medical device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set sample size, how ground truth was established for training set) are not applicable to this type of device.

The "acceptance criteria" here refers to the performance standards that the physical gloves must meet, primarily outlined in ASTM D 3578-95 and 21 CFR 800.20. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed on the gloves to demonstrate compliance with these standards.

Acceptance Criteria and Device Performance for MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated the exact number of gloves tested for each criterion. The document generally states "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20," which implies that the sample sizes specified by these standards were followed. ASTM D 3578 typically specifies sampling plans for lot acceptance.
• Data Provenance: The tests were conducted by Medtexx Industries (Thai) Company Limited, from Thailand. The data is based on retrospective testing of glove samples for regulatory submission.

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

• Not Applicable: This device is a physical product (examination gloves), not an AI/SaMD. "Ground truth" in this context refers to objective scientific measurements and established standards (ASTM D 3578-95, 21 CFR 800.20, USP iodine test) rather than expert consensus on interpretations.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this is a physical product. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in AI/SaMD contexts, not for objective physical or chemical tests of gloves. The "adjudication" is essentially the comparison of test results against the predefined quantitative and qualitative criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, Not Applicable: MRMC studies are specific to evaluating the diagnostic performance of human readers, often with and without AI assistance, in interpreting medical images or data. This is irrelevant for a physical product like examination gloves.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, Not Applicable: This concept applies to AI algorithms and their performance. The gloves themselves do not have an "algorithm" to be evaluated in a standalone manner.

7. The Type of Ground Truth Used

• The "ground truth" for the performance of these gloves is based on:
  • Established Industry Standards: Specifically, ASTM D 3578-95 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20 (dealing with freedom from holes).
  • Objective Laboratory Tests: For biocompatibility (primary skin irritation, delayed contact sensitization) and chemical analysis (USP iodine test for starch, measurement of water extractable protein).

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" for physical devices like these gloves. This concept is relevant for machine learning models.

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

• Not Applicable: As there is no training set, there is no ground truth, in the context of AI/ML, to be established for it.

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