Search Results

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.

Ask a specific question about this device

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

Powder-free Nitrile Examination Gloves

This document is a 510(k) submission for Lovytex Powder-free Nitrile Examination Gloves (K981179). The acceptance criteria and the study proving the device meets them are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, the tests are laboratory-based performances of the glove material. The manufacturer is Lovytex Sdn Bhd, located in Malaysia, suggesting the testing was likely conducted in Malaysia. The studies are prospective as they are tests performed on the Lovytex device to demonstrate compliance.

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

This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics of examination gloves is established by standardized testing protocols (e.g., ASTM standards, FDA pinhole requirements) and general biocompatibility assessments, not by expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable. The performance is determined by objective laboratory measurements against set standards, not by an adjudication process involving human review of cases.

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 diagnostic devices that involve human interpretation of images or other data. For examination gloves, the focus is on material properties and barrier integrity, not diagnostic accuracy.

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

Yes, the studies conducted are standalone evaluations of the device's physical and biological properties. There is no "algorithm" or human-in-the-loop component for examination gloves. The device's performance is assessed purely on its inherent characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Standardized Test Methods: Adherence to established industry standards like ASTM D 3578-95 for physical properties (e.g., tensile strength, elongation).
• Regulatory Requirements: Meeting FDA specific requirements, such as pinhole acceptance rates.
• Biocompatibility Testing: Results from established biological evaluation methods for medical devices (e.g., cytotoxicity tests, skin irritation tests).

8. The Sample Size for the Training Set

This concept is not applicable here. There is no "training set" for physical and biocompatibility testing of examination gloves as there is no machine learning or AI algorithm being developed. The tests are performed on representative samples of the manufactured gloves.

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

Not applicable, as there is no training set involved in this type of device submission.

Ask a specific question about this device

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

Powder-free Latex Examination Gloves

The provided text describes a 510(k) submission for "Powder-free Latex Examination Gloves" by Lovytex Sdn. Bhd. It includes acceptance criteria for the device and a summary of performance data.

Here's an analysis of the provided information, structured as requested:

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 sample sizes used for the various tests (Water Leak, Residual Powder, Tensile, Elongation, Water Extractable Protein, or biocompatibility tests).

The data provenance is Malaysia, as the applicant is Lovytex Sdn Bhd, located in Selangor Darul Ehsan, Malaysia.

The study appears to be retrospective in the sense that the data is presented as a summary of tests already conducted, presumably as part of the product development and validation process to meet established standards. It's not a prospective, controlled clinical trial.

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

This information is not provided in the document. The tests refer to compliance with ASTM and FDA standards, which are established protocols, but the details of who performed or verified these tests are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided. The assessment relies on meeting or exceeding established ASTM and FDA standards. There's no mention of a human adjudication process for interpreting the test results beyond the statement that the device "meets or exceeds" the standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with evaluating diagnostic imaging tools or AI-assisted diagnostic systems that rely on human-in-the-loop interpretation. The device described is a medical glove, which has different types of performance metrics.

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

Yes, in essence, standalone performance was assessed. The tests described (Water Leak, Tensile, Elongation, Water Extractable Protein, Biocompatibility) are objective, laboratory-based physical and chemical tests of the glove itself. These tests measure the inherent properties of the device without human interpretation as part of the performance metric. The "algorithm" here is the physical product and its manufacturing process, and the performance is measured directly against standards.

7. The Type of Ground Truth Used

The ground truth used for evaluating this device's performance is based on established industry standards and regulatory requirements. Specifically:

• ASTM Standards: For mechanical properties (Tensile, Elongation) and some general properties (Water Leak, Residual Powder, Water Extractable Protein).
• FDA Requirements: For pinhole requirements and implied biocompatibility standards.
• Expert Consensus (indirectly): The ASTM standards themselves are developed through expert consensus within the industry.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning or AI development. This device is a physical product (medical glove) and its performance is validated through physical and chemical testing, not through training an algorithm.

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

As the concept of a "training set" doesn't apply, this question is not relevant to the provided document.

Ask a specific question about this device