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A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.

The provided text is a 510(k) premarket notification for a medical device: "Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies often associated with AI/ML devices. Therefore, the questions related to AI/ML device testing (e.g., ground truth establishment by experts, MRMC studies, training set details) are not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the physical characteristics of the examination gloves, which are the relevant "performance" metrics for this device.

Here's the information based on the provided text, focusing on the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties: Data is provided for each size (XS, S, M, L, XL). The specific sample size for each test (e.g., number of gloves tested for tensile strength) is not explicitly stated, but the results represent the performance across these sizes.
• Dimension: Data is provided for each size (XS, S, M, L, XL).
• Watertight:
  • XS & XL: Sample size 200 pcs each.
  • S, M, L: Sample size 500 pcs each.
  • Data Provenance: The document does not specify the country of origin where the testing was conducted or if it was retrospective/prospective. It's non-clinical lab testing.
• Residual Powder: Sample size: 5 pcs.
• Extractable Protein Content: Sample size: 3 pcs.

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

Not applicable. This device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not clinical expert review of images or medical data. The "ground truth" is defined by the parameters of the ASTM standards and the test results.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against predefined standards, not subjective assessments requiring multiple reviewers or adjudication.

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

No. This is not an AI/ML device or a diagnostic device that would typically undergo MRMC studies.

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

Not applicable. This is a physical medical device (glove), not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established by international and national standards (e.g., ASTM D3578, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ASTM D5712-99, ISO 10993 series) for physical properties, biocompatibility, and manufacturing quality of medical gloves. These standards define the measurable acceptance criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Study Type:

The document describes non-clinical performance testing against established industry standards (ASTM, ISO) to demonstrate that the Natural Rubber Latex Examination Glove meets all relevant safety and performance requirements and is substantially equivalent to a legally marketed predicate device (K202377). It's a bench testing/laboratory study based on adherence to quantitative standards rather than a clinical trial or AI/ML model validation study.

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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 Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

This document is a 510(k) premarket notification for a medical device: "Powder Free Latex Examination Glove." It's not a study proving an AI/computer-aided device meets acceptance criteria, but rather a regulatory submission demonstrating substantial equivalence to a predicate device based on non-clinical performance data for a physical product (a glove).

Therefore, I cannot extract the information required to populate a table for acceptance criteria of an AI device, nor provide details about a study that proves an AI device meets acceptance criteria. The document does not describe:

• AI device performance metrics: The criteria and results are for physical glove characteristics (e.g., tensile strength, freedom of holes, dimensions).
• Sample size for test set or data provenance for an AI algorithm.
• Number of experts and their qualifications for establishing ground truth related to AI.
• Adjudication method for AI ground truth.
• MRMC study or effect size of AI assistance on human readers.
• Standalone AI performance.
• Type of ground truth (e.g., pathology, outcomes data) for medical images.
• Training set size or ground truth establishment for an AI model.

The document states:

• "8.0 Assessment of Clinical Performance Data: Not applicable - Clinical data is not needed." This further indicates the absence of a study similar to what would be done for an AI/CADe device.
• "7.0 Non-Clinical Performance Data: The performance test data of the non-clinical tests is reported in the table above." This refers to the physical and chemical properties of the glove.

In summary, this document is entirely unrelated to the type of AI/CADe device evaluation you're asking about. It's a regulatory submission for a simple Class I physical medical device (examination gloves).

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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 Latex Examination Glove, Polymer Coated

The provided text is a 510(k) clearance letter from the FDA for a Powder Free Latex Examination Glove, Polymer Coated. This document does not contain information about acceptance criteria or a study proving that an AI/ML-enabled device meets those criteria.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is specific to the evaluation of AI/ML performance in a medical device context. This document, however, pertains to a physical medical device (examination gloves) and its substantial equivalence to a predicate device based on its intended use and general controls.

Therefore, I cannot provide the requested information based on the input text.

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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 Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less

I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less." It primarily discusses the regulatory approval of the glove and its classification.

This document does not contain any information about:

• Acceptance criteria or device performance data for an AI/ML medical device.
• Study details such as sample sizes, data provenance, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Glove

This appears to be an FDA 510(k) clearance letter for a Class I medical device, specifically "Powder Free Latex Examination Gloves." This type of clearance focuses on demonstrating substantial equivalence to a predicate device, primarily through established performance standards and manufacturing controls, rather than extensive clinical study data.

Therefore, the document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria, as typically seen for higher-risk devices or AI/software-as-a-medical-device (SaMD) products.

Here's why and what kind of information would typically be needed for the questions you've asked, if this were a different type of device:

• For a Class I device like examination gloves: The "acceptance criteria" primarily relate to national/international standards for glove performance (e.g., ASTM standards for barrier integrity, dimensions, tensile strength, protein content for latex gloves). The "study" proving this would involve laboratory testing against these standards, typically performed by the manufacturer and submitted to the FDA as part of their 510(k) application to demonstrate conformance. The provided document is the outcome of that review, not the detailed submission itself.

If this were a more complex device (e.g., an AI/SaMD product), the requested information would look like this:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Would typically define specific thresholds for performance metrics (e.g., sensitivity ≥ 90%, specificity ≥ 85%, AUC ≥ 0.90, average reading time reduction ≥ X seconds). These would often be based on clinical need, predicate device performance, or stakeholder input.
   • Reported Device Performance: Would present the actual values achieved by the device in predefined test sets for those metrics, along with confidence intervals.

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

   • Sample Size: A specific number of cases/patients (e.g., 500 cases).
   • Data Provenance: Details like "retrospective, multi-center data from 3 hospitals in the USA and 2 in Europe" or "prospectively collected data from a single academic institution in Japan."

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

   • Number of Experts: E.g., "3 experts."
   • Qualifications: "Board-certified radiologists, each with over 10 years of experience in chest imaging, including sub-specialization in oncology."

4. Adjudication method for the test set:

   • Method: E.g., "2+1 consensus (if two experts agreed, that was the ground truth; if they disagreed, a third expert resolved the discrepancy)" or "majority vote among 3 readers."

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • Yes/No: Explicitly state if one was done.
   • Effect Size: "Readers improved their AUC by an average of 0.05 (from 0.85 to 0.90) with AI assistance, a statistically significant improvement (p < 0.001)." Or "AI assistance reduced average reading time per case by 15% (from 60 seconds to 51 seconds) while maintaining diagnostic accuracy."

6. Standalone performance study:

   • Yes/No: Explicitly state if one was done. This measures the algorithm's performance without integration into human workflow.

7. Type of ground truth used:

   • Type: E.g., "Expert consensus," "Histopathology confirmation (biopsy results)," "Longitudinal follow-up data (e.g., 6-month clinical outcomes and subsequent imaging)," "Disease-specific gold standard (e.g., culture for infection)."

8. Sample size for the training set:

   • Sample Size: A specific number of cases/patients (e.g., 10,000 cases).

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

   • Method: E.g., "Ground truth was established by a single experienced physician's review of clinical reports," "Automated extraction from electronic health records using natural language processing and validated by a physician review of a subset," or "Same method as the test set: 2+1 expert consensus."

In summary, the provided FDA clearance letter for examination gloves does not contain the detailed performance study information typically requested for AI/SaMD or more complex medical devices.

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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 LATEX EXMAINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 µg/dm² OR LESS

This document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Latex Examination Gloves with Protein Content Labeling Claim of 50 ug/dm2 or Less." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on confirming the substantial equivalence of the device to legally marketed predicate devices and outlines the regulatory obligations of the manufacturer. There is no performance data, study design, or expert review mentioned within this text.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue).

This document is a 510(k) premarket notification approval letter for "Powder Free Latex Examination Gloves, Tested For Use with Chemotherapy Drugs (Blue)". It is not a study that proves the device meets acceptance criteria in the sense of a clinical trial or AI algorithm validation. Instead, it demonstrates substantial equivalence to a predicate device, which includes fulfilling certain performance standards for medical gloves.

Here's an analysis based on the provided document, addressing the requested points where information is available:

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

The document focuses on the chemotherapy drug permeation aspect of the gloves. While it doesn't explicitly state "acceptance criteria" in a separate column, the values presented are the "Average Breakthrough Detection Time in Minutes" for various chemotherapy drugs, which would be compared against a standard or established threshold for acceptable performance. The implicit acceptance criterion is that the breakthrough time should be as long as possible, ideally exceeding the duration of typical exposure.

Note: The document explicitly states: "Please note that Thiotepa has an extremely low permeation time of less than 30 minutes." This indicates that for Thiotepa, the performance is below a generally accepted threshold for robust protection and needs careful consideration.

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

This information is not provided in the document. The document is an FDA approval letter, not a detailed study report. The results presented in the table are likely summarized from testing conducted by the manufacturer, but the specifics of the sample size (n for each test) and provenance are not included.

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 and not provided. This document pertains to the physical performance of a medical device (gloves) against chemical permeation, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the objective measurement of chemical breakthrough.

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

This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for chemical permeation testing of gloves.

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 document is for 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. This document is for a medical glove, not an algorithm.

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

The "ground truth" for the chemotherapy drug permeation data would be the objective measurement of the breakthrough time of the specific chemotherapy drugs through the glove material. This is determined by standardized chemical testing protocols (e.g., ASTM D6978 for medical gloves). It does not involve expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

This is not applicable and not provided. This is not an AI/machine learning device that requires a training set. The "training" for such a device would be the manufacturing process itself, aiming to meet established performance standards.

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

This is not applicable and not provided. As explained above, this is not an AI/machine learning device.

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A powder free 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.

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Natural Rubber Latex Examination Gloves:

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 explicitly state the specific sample sizes used for each of the tests (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Soluble Protein Level, Biocompatibility).

The data provenance is not specified beyond indicating these are "performance test data." It is highly likely these were conducted as prospective tests by the manufacturer, specifically for this submission. The country of origin of the data would be Malaysia, where WEAR SAFE (MALAYSIA) SDN. BHD. is located and conducted the testing.

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

This information is not provided in the document. The tests performed are objective, laboratory-based physical and chemical assays, and biocompatibility tests. They rely on standardized methods rather than expert interpretation of data like in an imaging study. Therefore, the concept of "experts establishing ground truth" in the way it might apply to medical imaging or diagnostics is not directly relevant here. The ground truth for these tests is defined by the objective measurement criteria of the specified ASTM and CFR standards.

4. Adjudication method for the test set:

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers might disagree on findings (e.g., radiologists interpreting images). Since these are objective physical, chemical, and biocompatibility tests, no adjudication method in this sense would have been used. The results are based on direct measurements and observations according to the test protocols.

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 MRMC comparative effectiveness study was done. This device is a patient examination glove, a physical product, not an AI-powered diagnostic or assistive technology. The concept of "human readers improving with AI assistance" is not applicable to this type of device.

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

No standalone algorithm performance study was done. This is a physical non-AI device.

7. The type of ground truth used:

The ground truth for these tests is based on objective measurement criteria and thresholds defined by established international standards:

• ASTM D3578-05 for Dimensions
• ASTM D 412-06ae1 for Physical Properties
• ASTM D 5151-06 for Freedom from pin-holes
• ASTM D 6124-06 for Powder Free Residue
• ASTM D 5712-05 for Soluble Protein Level
• ASTM F720-81 for Dermal Sensitization
• 16CFR Part 1500 for Primary Skin Irritation Test

These standards specify the methodology and acceptable limits for each characteristic.

8. The sample size for the training set:

Not applicable. This 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:

Not applicable, as there is no training set for this type of device.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove is tested for use with Dacarbazine (DTIC), Cyclophosphamide (Cytoxan), Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol)

Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Powder Free Latex Examination Gloves, Blue Tested For Use With Chemotherapy Drugs

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Latex Examination Gloves, Blue Tested for Use With Chemotherapy Drugs".

The document does not contain any information regarding acceptance criteria for a study, reported device performance, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, this letter is an administrative notification that indicates the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, regulation name, product code, and the indications for use. It also outlines the manufacturer's responsibilities under the Act.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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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.

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.

Here's a breakdown of the acceptance criteria and study information for the "Powderfree Latex Examination Gloves" described in the provided documents:

The documents provided are a 510(k) Summary and an FDA substantially equivalent letter for "Powderfree Latex Examination Gloves" manufactured by PT. Maja Agung Latexindo. This type of regulatory filing demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.

Therefore, the study design and "acceptance criteria" here refer to meeting established industry standards for similar devices and demonstrating equivalence to a legally marketed predicate device.

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 in the provided documents. For physical property testing of gloves adhering to ASTM standards, specific sample sizes are typically defined within the ASTM standard (e.g., ASTM D3578-05ae2 for latex examination gloves specifies sampling plans for various tests like dimensions, physical properties, and watertightness).
• Data Provenance: The manufacturing location is "Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA". The testing data would originate from the manufacturer's quality control or third-party testing facilities related to their manufacturing process. The data is retrospective, as it refers to tests conducted on manufactured batches to ensure compliance with the standard.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance specifications of these gloves is defined by the ASTM D 3578-05ae2 Standard and FDA's pinhole requirements. These are engineering and performance specifications, not subjective expert interpretations of medical images or outcomes. The "experts" involved would be the engineers and quality control personnel who conducted the tests and verified compliance with the standard.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted for glove performance (tensile strength, elongation, dimensions, pinhole) are objective measurements against a defined standard.

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. It is a device 510(k) submission for examination gloves, which are physical medical devices, not diagnostic software.

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

• Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• The ground truth used is established industry standards and regulatory requirements, specifically:
  • ASTM D 3578-05ae2 Standard for Powder-Free Latex Examination Gloves
  • FDA pinhole requirement for examination gloves.
  • The specifications defined in the 510(k) summary for dimensions and physical properties, which are derived from or meet these standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device manufacturing and regulatory submission. The gloves are manufactured and tested against predefined specifications.

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

• Not applicable, as there is no training set for this type of device. The specifications for performance (ground truth) were established over time through industry consensus and regulatory guidance, leading to standards like ASTM D 3578-05ae2.

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