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Blue Colour, Chlorinated Powder Free Nitrile Examination Glove 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.

The Blue Colour, Chlorinated Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 00a Standard Specification for Nitrile Examination Gloves for Medical Application1. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are blue in color and are powder free.

The provided FDA 510(k) summary is for a medical device that is not an AI/ML powered device. The device is "BLUE COLOUR, CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES." Therefore, the requested information regarding AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment, is not applicable to this submission.

The summary describes the device's adherence to established standards for examination gloves.

Here's a breakdown of the relevant information provided for this non-AI device:

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)

• Sample Size for Non-Clinical Tests: Not explicitly stated in terms of an exact number of gloves. The studies refer to "testing performed per ASTM D 6319 - 00a," and "Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs." ASTM standards typically specify sampling plans, but the specific numbers for this submission are not detailed.
• Data Provenance: The manufacturing company, MEDTEXX MANUFACTURING SDN. BHD., is located in Malaysia. The testing would presumably be conducted by or for this manufacturer. The nature of these tests (material properties, biological safety) makes the "origin of data" less about observational patient data and more about laboratory and animal testing. These are inherently prospective tests on the product itself.

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 as the device is not an AI/ML system that requires expert interpretation to establish a ground truth. The "ground truth" for these gloves is their physical properties and biological safety as measured by established laboratory and animal testing protocols, which are objective and do not rely on human expert consensus interpretation of complex data like medical images.

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

• This question is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations or complex diagnostic tasks where multiple human readers might disagree. The tests performed for examination gloves are standardized physical and biological assays.

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 as the device is not an AI/ML system and does not involve human readers interpreting data.

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

• This question is not applicable as the device is not an AI/ML algorithm.

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

• The "ground truth" for this device's performance is based on objective measurements and observations from standardized physical, chemical, and biological tests following ASTM D 6319 - 00a and 21 CFR 800.20. This includes:
  • Physical properties (e.g., tensile strength, elongation, dimensions, freedom from holes)
  • Chemical properties (e.g., powder residue if applicable, though these are powder-free)
  • Biocompatibility (primary skin irritation in rabbits, delayed dermal contact sensitization in guinea pigs).

8. The sample size for the training set

• This question is not applicable as the device is not an AI/ML system and does not have a "training set."

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

• This question is not applicable as the device is not an AI/ML system and does not have a "training set."

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Powdered Natural Rubber Latex Examination Glove 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.

Powdered Natural Rubber Latex Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powdered.

The device being discussed is "POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES".

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

1. Table of Acceptance Criteria and Reported Device Performance

The device is marketed as substantially equivalent to a Class I Patient Examination glove (product code 80LYY) and is required to meet the specifications of ASTM D 3578-05, Standard Specification for Rubber Examination Gloves, and 21 CFR 800.20.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the specific performance tests (e.g., tensile strength, elongation, barrier integrity as per ASTM D 3578-05). However, such standards typically specify sampling plans. For the biocompatibility tests:
  • Primary skin irritation: Not specified, but generally a small number of rabbits are used (e.g., 3-6).
  • Delayed dermal contact sensitization: Not specified, but generally a small number of guinea pigs are used (e.g., 10-20).
• Data Provenance (Country of Origin): The studies were likely conducted in Malaysia, as the submitter's address is Malaysia.
• Retrospective or Prospective: The non-clinical tests described were prospective studies specifically conducted for this 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 for a device like examination gloves. The "ground truth" for glove performance is established by objective measurements against engineering standards (ASTM D 3578-05) and biological response in animal models, not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" involves objective measurements and animal studies, not 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. This device is an examination glove, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC comparative effectiveness study was performed.

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

This is not applicable. This device is an examination glove, not an algorithm or software. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

• For performance characteristics (e.g., strength, dimensions, barrier integrity): The ground truth is defined by the objective measurement specifications and tolerances outlined in ASTM D 3578-05. For example, a glove "passes" if its tensile strength exceeds a specific value.
• For biocompatibility: The ground truth for irritation and sensitization is based on the observed biological reactions in the animal models according to established toxicological testing protocols. "No irritation or sensitization" is the ground truth observed against the control group or baseline.

8. The Sample Size for the Training Set

This is not applicable. Examination gloves are manufactured using established processes; there is no "training set" in the context of machine learning or AI involved in their development or validation. The manufacturing process itself is continually optimized, but this is distinct from an AI 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 in the context of the provided information.

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Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.

The provided document is a 510(k) summary for "NON-CHLORINATED, POLYMER COATED, POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES." This pertains to a medical device (examination gloves) and not a software algorithm. Therefore, many of the questions asked about acceptance criteria and study design for software performance are not directly applicable.

However, I can extract the information that is relevant to the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" for this physical device.

Here's the breakdown based on the document:

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 specify the sample sizes used for the non-clinical tests. The tests were performed by MEDTEXX MANUFACTURING SDN. BHD. in Malaysia. These were non-clinical (laboratory and animal-based) tests, presumably prospective as they were conducted to support the 510(k) submission.

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

This question is not applicable. The device is evaluated against engineering standards (ASTM D 3578-05) and regulatory guidelines (21 CFR 800.20) for material properties and biocompatibility. There is no concept of "expert ground truth" in the diagnostic sense for this type of device.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation of medical images or data by multiple experts. For physical device testing against standards, the results are typically objectively measured and compared to predefined thresholds.

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. MRMC studies and the concept of AI assistance are related to diagnostic software or tools that aid human interpretation. This document describes a physical medical device (examination gloves), not a diagnostic algorithm.

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

This question is not applicable as the device is a physical product, not a software algorithm.

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

The "ground truth" for this device's performance is defined by:

• ASTM D 3578-05 Standard: This standard specifies physical properties such as tensile strength, elongation, and dimensions for rubber examination gloves.
• 21 CFR 800.20: This regulation outlines biocompatibility requirements, which are assessed through tests like primary skin irritation and delayed contact sensitization.
• USP iodine test: Used to determine the absence of starch.

These are objective, measurable standards, not observational or interpretive ground truth established by experts in a clinical context.

8. The sample size for the training set

This question is not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical product against established engineering and biocompatibility standards.

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

This question is not applicable for the same reason as above. There is no training set for this type of device.

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