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A powder-free 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

Latex Exam Gloves are formulated using Natural Rubber Latex. The device is offered powder-free and sterile.

This document describes the safety and effectiveness of "Sterile Latex Powder Free Exam Gloves" by Cardinal Health, submitted under 510(k) K081464. The purpose is to demonstrate substantial equivalence to a predicate device (Cardinal Health's Powder-Free Latex Exam Gloves, K024292).

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 sizes used for each specific test (e.g., number of gloves tested for elongation, tensile strength, or barrier defects). The data provenance is internal to Cardinal Health, as indicated by "Cardinal Health internal AQL is 1.5" and "Results generated values below 2 mg of residual powder per glove." The tests are likely conducted on product batches as part of quality control and product validation.

• Country of Origin of the Data: Not explicitly stated, but assumed to be from Cardinal Health's manufacturing and testing facilities.
• Retrospective or Prospective: These tests are typically prospective, performed on manufactured products to ensure they meet specifications.

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

This type of device (exam gloves) does not typically involve expert "ground truth" establishment in the medical imaging or diagnostic sense. The "ground truth" here is objective, measurable physical and chemical properties and biological safety assessments, measured against established industry standards (ASTM, ISO, CFR). The "experts" would be the personnel performing the laboratory tests (e.g., chemists, materials scientists, microbiologists, toxicologists) who are qualified to conduct these tests according to the specified standards, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on established physical, chemical, and biological testing methods. There is no subjective interpretation requiring adjudication among multiple experts. The results are quantitative (e.g., elongation values, tensile strength values, AQL levels, powder weight) or qualitative (e.g., "non-irritating," "no sensitization potential") determined by standardized procedures.

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 a medical device (exam glove) submission, not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

Not applicable. This is a medical device (exam glove) submission, not an AI/algorithmic device.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Established Industry Standards: ASTM D 3578 (for latex exam gloves), ASTM D 6124 (for residual powder), ANSI, AAMI, ISO 11607 Parts 1 & 2 (for packaging integrity). These standards define the acceptable range or threshold for various performance metrics.
• Regulatory Requirements: 21 CFR Section 800.20 (for AQL/barrier defects) and general biological safety principles underlying primary skin irritation and sensitization tests.
• Internal Specifications: Cardinal Health's internal AQL of 1.5, which is a stricter requirement than the regulatory and ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (exam glove) submission, not an AI/learning algorithm. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for this type of device, this question is not relevant.

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A patient examination gloves is a disposable device intended for medical purposes worm on the examiner, s hand to prevent contamination between patient and examiner. This gloves is intended for medical and dental use.

Powder Free Latex Exam gloves Blue

This document is a 510(k) Summary for Betelcare Sdn Bhd's Latex Exam Gloves, Blue, Powder Free, Non Sterile. It describes the device's characteristics and how it meets acceptance criteria, primarily through comparison to established ASTM standards.

Here's an analysis of the provided information:

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 sizes used for testing each characteristic. It simply states that the "device meets or exceeds the ASTM Std or Equivalent Standards and FDA pin hole requirements" and provides "Assesment of Non clinical Performance Data" and "Assesment of Biocompatibility."

The data provenance is Malaysia (West Malaysia, specifically Kapar, Selangor Darul Ehsan), as the applicant Betelcare Sdn Bhd is located there and conducts the testing. The data appears to be prospective as it is submitted for premarket notification of a new device.

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. The testing relies on adherence to established ASTM standards and FDA requirements, which implies a standardized test procedure rather than expert consensus on individual cases for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this type of device testing. The assessment is based on a device meeting pre-defined quantitative and qualitative standards (ASTM, FDA) rather than human adjudication of performance on a test set.

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

No, a MRMC comparative effectiveness study was not done. This document describes the performance of a medical device (exam gloves) against established industry standards. MRMC studies are typically performed for diagnostic or AI-driven systems where human interpretation is a critical component.

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

Yes, in essence. The testing described is a standalone assessment of the physical and biological properties of the examination gloves. There is no "human-in-the-loop" performance in the sense of a diagnostic algorithm assisted by a human. The product's performance (e.g., water leak, tensile strength) is evaluated directly against a standard.

7. The Type of Ground Truth Used

The ground truth used is primarily standardized quantitative measurements against established industry specifications (ASTM D 5151-06, ASTM D 6124-06, ASTM D 3578-05, ASTM D 5712-05e1) and regulatory requirements (FDA pin hole requirements, biocompatibility tests). These standards define acceptable levels of performance.

8. The Sample Size for the Training Set

This information is not applicable or provided. This is a medical device approval summary, not a machine learning model. There is no "training set" in the context of developing examination gloves. The manufacturer would have internal R&D and quality control processes to ensure the product consistently meets specifications, but these are not referred to as "training sets."

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

This information is not applicable for the reasons stated above.

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The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F and with Protein Labelian Claim (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of 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 Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.

The provided document is a 510(k) premarket notification for "Non-Sterile, Powder-Free, Latex Examination Gloves" and does not describe a study involving an algorithm or AI. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets them in the context of AI/algorithm performance.

However, I can extract the acceptance criteria and reported performance for the latex examination gloves as presented in the document, which primarily focuses on physical and chemical properties of the gloves.

Here's the information based on the provided text, adapted to the closest relevant categories:

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

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The Powder Free Patient Examination Gloves 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 hand for medical purposes to provide a barrier against potential infectious materials and other contaminants.

Powder Free Latex Examination Gloves

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) substantial equivalence letter for "Powder Free Latex Examination Gloves" and does not contain information about specific performance acceptance criteria or details of a study conducted to demonstrate the device meets such criteria.

The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. It does not include efficacy or performance study details.

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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, Natural and/or Colored Latex Exam Gloves, with Protein labeling (

This document describes the acceptance criteria and performance of Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (

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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.

POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES

Here is an analysis of the provided information regarding the acceptance criteria and the study for the device:

Device Name: POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
510(k) Number: K023590

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

The provided document describes performance testing conducted to demonstrate that the device meets established standards.

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

• Sample Size: Not explicitly stated for each specific test, but the "Watertight (1000ml)" test mentions "Multiple Normal GI AQL = 2.5," which refers to an Acceptance Quality Limit sampling plan. This implies a statistical sampling method was used based on the AQL, but the exact number of units sampled is not provided.
• Data Provenance: The manufacturer is YTY INDUSTRY (MANJUNG) SDN BHD, suggesting the data originates from testing conducted by or for this Malaysian company. The document does not specify if the data is retrospective or prospective.

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 as the study involves objective physical and chemical performance tests of latex gloves, not diagnostic interpretation or clinical assessment by experts. The "ground truth" is defined by the technical specifications and standard requirements (e.g., watertight, length, tensile strength).

4. Adjudication method for the test set:

• This information is not applicable for these types of performance tests. Adjudication methods are typically used when there are subjective interpretations or conflicting expert opinions, which is not the case for physical property measurements or watertight tests.

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. The device is Latex Exam Gloves, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance metrics are irrelevant.

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

• This information is not applicable. The device is a physical product (latex gloves), not an algorithm or software.

7. The type of ground truth used:

• The ground truth is based on objective technical standards and measurements. Specifically, the listed ASTM standards (ASTM D3578-01/AE2, ASTM D5712-99, ASTM D6124-01, ASTM D5151-99), FDA watertight test (1000ML), ISO 2859, and established bio-compatibility tests (Dermal Sensitization, Primary Skin Irritation). These standards define the acceptable range or threshold for each performance characteristic.

8. The sample size for the training set:

• This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

• This information is not applicable for the same reason as 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.

POWDERED LATEX EXAM GLOVES, WITH PROTEIN LABELING (200 ug/g or less)

The provided document describes a 510(k) submission for powdered latex exam gloves. It does not describe an AI/ML powered device, therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's the information extracted from the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document does not explicitly state the sample size for each test conducted (e.g., number of gloves tested for each ASTM standard or biocompatibility).
   • Data Provenance: The tests were performed by the manufacturer, Hycare International Co., Ltd. (Thailand), implying in-house or contracted testing. The country of origin of the data is not specified beyond the manufacturer's location in Thailand. The study is prospective in nature, as new testing was conducted on the device to demonstrate conformance to standards.

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

   • N/A. This is a medical device (exam glove) submission, not an AI/ML-powered diagnostic or screening device. The "ground truth" here refers to the physical and biological performance of the glove as measured against established industry standards. These standards (ASTM, ISO) define objective measurement methods and acceptance limits, rather than relying on expert consensus for "ground truth" in the way an AI diagnostic system would.

3. Adjudication method for the test set:

   • N/A. As above, this is a physical medical device. Performance is determined by objective measurements against predefined standards (e.g., tensile strength, barrier integrity, protein content, skin reaction) rather than a panel of experts adjudicating results.

4. 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:

   • N/A. This is not an AI/ML-powered device.

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

   • N/A. This is not an AI/ML-powered device.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is based on objective measurement against established industrial and medical standards (ASTM, ISO, and biocompatibility tests). These standards define the acceptable range for physical properties and biological responses, as detailed in the "Acceptance Criteria" table.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device, so there is no training set in the typical machine learning sense. The manufacturing process is validated through quality control and adherence to standards, but not a "training set."

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

   • N/A. Not applicable for this type of device.

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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.

Device beser patient examination gloves 80LYY, powder free and meeting all the requirements Class Plater parts of Specification for Latex Examination Gloves for Medical Application.

This request is about a medical device, but the provided text describes a "NON-STERILE POWDER FREE CHOCOLATE SCENTED LATEX EXAM GLOVES". This type of product is a medical device, but it is not an AI/ML powered device, so acceptance criteria and study information mentioned in the request are not applicable.

However, since there are acceptance criteria and study data on device performance, I will provide the information accordingly.

Acceptance Criteria and Device Performance for Powder-Free Chocolate Scented Latex Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

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