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A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3578.

This document is a 510(k) summary for a medical device: "Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein."

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein will meet all the current specification for ASTM D3578.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for Wear Safe (Malaysia) Sdn.Bhd. Powder Free Polymer Coated Latex Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

Based on the provided document, the study conducted is a non-clinical performance evaluation against established standards for patient examination gloves.

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample size used for each test. However, it indicates that the tests were performed according to specified ASTM and ISO standards, which inherently include sampling methodologies. The provenance of the data is Malaysia, as the manufacturer is "Wear Safe (Malaysia) Sdn.Bhd." The data is retrospective in the sense that it reflects testing performed on product samples to demonstrate compliance at the time of 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 information is not applicable to this type of device and study. The "ground truth" for the performance characteristics is established by adherence to the highly standardized and objective testing methods outlined in the ASTM and ISO standards. These standards themselves are developed by expert committees, but the immediate study does not involve human expert adjudication of individual test results in the way it would for, say, diagnostic image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   None in the context of human expert adjudication. The "adjudication" is met by following the prescribed methodology of the ASTM and ISO standards. For instance, pinhole testing involves visual inspection of water-filled gloves, and if a leak is observed, it's a pinhole. There isn't an "expert consensus" on whether a pinhole exists; it's a direct observation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, and this type of study is not relevant for examination gloves. MRMC studies are typically performed for diagnostic devices (e.g., AI for radiology) where human interpretation is a key component. This device is a barrier protection product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" is defined by the objective measurement and observation protocols outlined in the referenced ASTM and ISO standards. For example:

   • Dimensions: Measured against specified ranges in ASTM D3578.
   • Physical Properties: Tensile strength, elongation, etc., measured using ASTM D 412.
   • Freedom from pin-holes: Evaluated according to ASTM D 5151 (e.g., water leak test).
   • Powder Free Residue: Measured using ASTM D 6124.
   • Biocompatibility: Determined through specific in vivo (e.g., animal or human patch tests, though the document doesn't specify if human or animal for this submission) tests following ISO 10993-10 guidelines, where the "ground truth" is the observed biological response (e.g., absence of sensitization or irritation).

8. The sample size for the training set:
   Not applicable. There is no "training set" as this is a physical product, not a machine learning model.

9. How the ground truth for the training set was established:
   Not applicable. There is no training set for this type of device.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient

Powder Free Polymer Coated Latex Examination Glove

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Polymer Coated Latex Examination Gloves". It does not describe acceptance criteria for a study or provide data on device performance. Instead, it indicates that the device has been found substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, etc.) from this document.

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A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the examiner's hand or finger's for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Powder-Free Polymer-Coated Latex Examination Gloves

The provided text describes a 510(k) premarket notification for "Ever-More Powder-Free Polymer-Coated Latex Examination Gloves." This is a regulatory document affirming substantial equivalence to a predicate device, not a study reporting on the performance of a medical device against acceptance criteria in the manner of AI/ML or imaging diagnostics.

Therefore, none of the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or training/ground truth establishment is present in the provided document.

The document details the regulatory classification of the device (Class I), its regulation number (880.6250), product code (LYY), and its intended use as a barrier against potentially infectious materials. It also confirms that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not available. This document is about regulatory clearance, not performance testing.
2. Sample sizes used for the test set and data provenance: Not applicable. No test set described.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth establishment for a test set.
4. Adjudication method for the test set: Not applicable. No test set adjudication.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML or imaging diagnostic device.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a physical glove, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.

The provided text is a 510(k) summary for a medical device, specifically non-sterile powder-free polymer-coated latex examination gloves. It details the device's technical specifications and how its performance was evaluated against established standards for regulatory clearance. It does not describe a study involving an AI-powered device or human readers.

Therefore, many of the requested categories regarding AI, expert involvement, and MRMC studies are not applicable to this document.

Here's the information that can be extracted from the provided text, structured according to your request where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of gloves) used for each individual test. It states that "Performance data of gloves based on ASTM D3578-95 and FDA 1000ML watertight test" were conducted. ASTM standards typically define sampling plans, which would have been followed, but the specific numbers are not in this summary.

Data Provenance: The testing was conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia). The data would be prospective, as it was generated specifically for this 510(k) submission to demonstrate compliance with the standards.

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

Not applicable. The "ground truth" for this device is defined by physical and chemical performance standards (ASTM D3578-95 and FDA requirements), not expert consensus on interpretations of data. The tests are objective measurements.

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

Not applicable. This is not a study requiring expert adjudication of results. The tests are based on direct measurement and comparison against predefined thresholds in 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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth is defined by established industry standards (ASTM D3578-95) and regulatory requirements (FDA's 1000ML watertight test, powder content, and protein content limits). These are objective, measurable criteria for glove performance.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.

Powder-free Polymer Coated Latex Examination Gloves with protein label claim 50 micro-grams per gram

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder-free Polymer Coated Latex Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample size used for the test set for any of the performance characteristics (e.g., water leak, tensile strength, protein content, biocompatibility tests).

The data provenance is retrospective, as this is a 510(k) submission summarizing data already collected. The country of origin of the data is implicitly Malaysia, given that the applicant, Lovytex Sdn Bhd, is based in Malaysia.

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

This information is not provided in the document. For performance tests on examination gloves, the "ground truth" is typically established by the standardized testing methodologies themselves (e.g., ASTM standards) rather than by human expert consensus or interpretation of images. Biocompatibility tests are also performed by trained laboratory personnel following specific protocols.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., image analysis by multiple radiologists) to resolve discrepancies. For objective performance tests of physical properties and chemical composition, such adjudication is not relevant.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being assessed. This submission is for an examination glove, which does not involve human interpretation in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This question is not applicable to an examination glove. This is not an AI-driven device with an algorithm that performs tasks independently. The performance listed is that of the physical product itself.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements against established industry standards and regulatory requirements. Specifically:

• ASTM (American Society for Testing and Materials) standards for physical properties (Water Leak, Residual Powder, Tensile, Elongation @ Break, Water Extractable Protein).
• FDA Pinhole requirements.
• Biocompatibility test results (Cytotoxicity, Rabbit Skin Irritation, Guinea Sensitization Study) which have defined pass/fail criteria.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a "training set." The product's properties are inherent to its manufacturing process and materials.

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

This information is not applicable for the reasons stated in point 8.

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