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Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. The gloves are lined with cotton flock, ambidextrous with beaded cuff, black colored, single use disposable devices that comes is six sizes (XS, S, M, L, and XL) supplied in non-sterile state. The gloves are made of synthetic rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical and performance characteristics meet all requirements of ASTM D6319-10. Powder was not used for this glove's manufacturing process.

This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Flock-Lined, Black Color." The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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 sample sizes for the testing of the new device for dimensions, physical properties, freedom from pinholes, or powder residual. It only states "Meets" for these criteria.

For biocompatibility, the tests were conducted according to ISO 10993-10:2010. The specific number of rabbits used for primary skin irritation or the number of subjects for dermal sensitization tests is not mentioned.

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in relation to the specific tests performed for the new device. However, the manufacturer is stated as "ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD" in ZHANGJIAGANG CITY, CHINA. This suggests the testing data likely originated from China.

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 and not provided in the document. The device in question is a medical glove, and its performance is evaluated against established ASTM and ISO standards for physical characteristics and biocompatibility, not through human expert assessment of a "ground truth" like in imaging or diagnostic AI.

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

This information is not applicable and not provided. The testing involves objective physical and chemical measurements against pre-defined standards, not a subjective assessment requiring adjudication among experts.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation. This document pertains to a medical glove.

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

This is not applicable as the device is a medical glove, not an algorithm or AI system.

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

The "ground truth" in this context is defined by the established ASTM and ISO standards for nitrile examination gloves. These standards specify acceptable ranges and methodologies for evaluating dimensions, physical properties (tensile strength, elongation), freedom from pinholes, powder residue, and biocompatibility.

8. The sample size for the training set

This is not applicable. The device is a physical product (medical glove) and not an AI/ML algorithm that requires a 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.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.

The provided 510(k) summary (K121528) describes the acceptance criteria and performance of Powder-Free Blue Nitrile Examination Gloves, Peppermint Scented. The study is a non-clinical performance assessment comparing the new device against established standards and a predicate device (K090194).

Here's a breakdown of the requested 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 each specific test (e.g., number of gloves tested for pinholes, physical properties, etc.). It only mentions that the device "Meets" the standards, implying that adequate samples were tested to demonstrate compliance.

The data provenance is retrospective and non-clinical. The testing was conducted on samples of the new device and compared against established ASTM standards and the characteristics of a predicate device. The origin of the data (country where tests were performed) is not specified, but the manufacturer is based in China.

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

Not applicable. This device is a medical glove, and the acceptance criteria are based on objective, standardized physical and chemical tests (ASTM standards, FDA regulations), not on subjective expert interpretation of medical images or patient data. Therefore, "ground truth" as established by medical experts is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment relies on objective measurements against predefined standards, not on human interpretation requiring adjudication.

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

No. An MRMC study is not relevant for this type of device. This is a non-clinical performance evaluation of a glove, not an imaging diagnostic device or a device requiring human reader interpretation.

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

Not applicable. This device is not an algorithm or an AI-powered system. It is a physical medical device (examination glove). The performance described is its inherent physical and biological characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by established consensus standards and regulatory requirements. Specifically:

• ASTM International Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension).
• FDA Regulations: Specifically, 21 CFR 800.20 ("Patient examination gloves").
• Biocompatibility Testing Guidelines: Primary Skin Irritation and Dermal Sensitization tests are standard biological evaluation methods for medical devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance is evaluated through physical and chemical testing of manufactured gloves.

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 ground truth for the performance evaluation is established by the referenced ASTM and FDA standards and recognized biocompatibility testing methods.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The Powder-Free Nitrile Examination Gloves, Orange is substantial equivalent to Powder-Free Nitrile Examination Gloves, Black Color with 510k number K090194 that is currently marketed. The device modification is a change in color from Black to Orange. Another device modification is the addition of adding a citric acid coating to the interior surface of the gloves to achieve a pH of 5.0 - 5.5 for the inner surface of the glove.

The provided document is a 510(k) Summary for Powder-Free Nitrile Examination Gloves, Orange Color. It describes the device, its intended use, and a summary of technological characteristics compared to standards. The document does not describe a study in the context of an AI/ML medical device with the information requested (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, or specific ground truth types like pathology or outcomes data).

Instead, this document is a submission to the FDA demonstrating substantial equivalence for a medical device (gloves) by confirming its compliance with established performance standards.

Therefore, many of the requested fields cannot be filled from the provided text as they are not applicable to this type of device submission.

Here's an attempt to answer based on the provided document, using "N/A" where information is not present or not relevant to the type of device:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated. The tests are described as conforming to ASTM standards and FDA regulations, which imply specific sample sizes for various tests (e.g., AQL 2.5 for pinholes), but these specific numbers are not detailed in the summary.
• Data Provenance: Not specified, but generally, such tests are performed by the manufacturer or a contracted lab to confirm compliance with regulatory standards.
• Retrospective/Prospective: Not applicable in the context of this device type. These are physical/chemical performance tests.

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

• Number of experts: N/A. The "ground truth" for these tests are the established ASTM standards and FDA regulations.
• Qualifications of those experts: N/A.

4. Adjudication method for the test set

• N/A. Compliance is determined by meeting pre-defined physical and chemical specifications, not by expert 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

• N/A. This is not an AI/ML device, and no MRMC study was conducted.

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

• N/A. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for the device's performance is compliance with established physical, chemical, and biological standards (ASTM D6319-10, ASTM D 6124-06, FDA 21 CFR 800.20, and biocompatibility tests like Primary Skin Irritation and Dermal Sensitization). It is based on pre-defined engineering and regulatory specifications.

8. The sample size for the training set

• N/A. No "training set" in the context of an AI/ML algorithm is applicable to this device.

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

• N/A. No "training set" is applicable.

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A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The Surgical Glove is made of all natural rubber, sterile, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.

The provided text describes a 510(k) summary for surgical gloves, which are medical devices and not typically subject to the same kind of "AI model performance" studies as software algorithms. The request asks for details that are common for AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance), but these are not relevant for the described device (surgical gloves).

Therefore, I will extract the available acceptance criteria and device performance based on the provided document. I will also explicitly state that the other requested information (sample size for test set, experts for ground truth, adjudication, MRMC, standalone performance, training set details) is not applicable or not provided for this type of device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Additionally, the conclusion states the device meets "FDA requirements for water leak test on pinhole AQL" and "glove performance standards."

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

This information is not applicable or not provided for this type of medical device (surgical gloves). Device performance is typically evaluated against established ASTM and ISO standards, which define testing methodologies and sample sizes within those standard documents, rather than through independent "test sets" in the context of an AI/ML algorithm. The data provenance would refer to the materials and manufacturing process.

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 or not provided. The "ground truth" for surgical glove performance is established by the specified ASTM and ISO standards and their associated test methods, not by expert consensus on data interpretation.

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

This information is not applicable or not provided. Adjudication methods are relevant for subjective interpretations, often in image analysis or clinical diagnosis. Surgical glove testing involves objective physical, chemical, and biological 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 or not provided. MRMC studies are used for evaluating the impact of diagnostic aids (often AI) on human reader performance. This submission is for a physical medical device (surgical gloves).

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

This information is not applicable or not provided. This concept applies to standalone software algorithms or AI models, not to physical devices like surgical gloves.

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

The "ground truth" for this device is based on objective measurements defined by international and national standards (ASTM D 3577-09e1, ASTM D 6124-06, ASTM D 5712-10, ISO 11137-2:2006) and established biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization). For instance, freedom from pinholes is measured by a water leak test, and protein level via a standard chemical assay.

8. The sample size for the training set

This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML model, which is not relevant for surgical gloves.

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

This information is not applicable or not provided.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)

Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D6319-00a(2005) and FDA 21 CFT 880.6250.

The provided text describes the acceptance criteria and performance for "Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs" (K101436). It focuses on the physical properties and, most significantly, the resistance to permeation by chemotherapy drugs.

Here's an analysis based on the provided document:

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 used for the test set for each specific characteristic. It refers to compliance with ASTM standards. For instance, for Resistance to permeation by Chemotherapy Drugs, it refers to ASTM D6978-05. This standard would specify the number of samples required for testing. For Freedom from pinholes, it mentions "AQL 2.5," which is an Acceptance Quality Limit and implies a specific sampling plan, but the exact number of gloves tested isn't stated.

Data Provenance: The data appears to be prospective, generated specifically for this 510(k) submission to demonstrate compliance with the referenced ASTM standards. The country of origin of the data is not specified beyond being submitted by Shen Wei (USA) Inc.

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

This type of medical device (nitrile examination gloves) does not typically involve human experts to establish "ground truth" in the way a diagnostic imaging AI algorithm would. The "ground truth" for the performance characteristics (e.g., tensile strength, pinholes, chemical permeation) is established through standardized laboratory testing procedures as defined by the relevant ASTM (American Society for Testing and Materials) standards. The results are objective measurements rather than subjective expert interpretations. Therefore, no information on "number of experts" or their "qualifications" for ground truth establishment is provided or relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by objective measurements based on standardized testing, not by expert consensus requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and AI assistance can impact their performance. Nitrile examination gloves are a physical barrier device, and their performance is evaluated through material science and chemical permeation tests, not through human interpretation tasks.

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

Yes, the performance reported for the gloves for all characteristics (dimensions, physical properties, pinholes, powder residual, biocompatibility, and chemotherapy drug permeation) represents the standalone performance of the device without human-in-the-loop. The tests are designed to measure the inherent properties of the glove material.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the device's performance claims is based on objective measurements derived from standardized laboratory tests defined by ASTM (American Society for Testing and Materials) standards. This is often referred to as analytical performance or technical performance data.

• For physical properties, it's measurements against ASTM D 6319-00a05.
• For freedom from pinholes, it's a test against ASTM D 5151-06.
• For powder residual, it's a test against ASTM D 6124-06.
• For biocompatibility, it's a test for primary skin irritation and dermal sensitization.
• For resistance to chemotherapy drugs, it's permeation testing according to ASTM D6978-05.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product (nitrile gloves), not an algorithm or an AI system that requires a "training set." The concept of a training set is relevant for machine learning models, which are not involved in the development or testing of these gloves.

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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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is single use only.

The Pearlescent Black Textured Powder- Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with (Protein Content Labeling Claim) Contains 50 micrograms or less of Total Water Extractable Protein per gram which had been submitted and cleared under 510(k) number K013793. The difference in this submission is: a) Change of color to be Pearlescent Black.

The provided document describes the acceptance criteria and performance of "Pearlescent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with Protein Content Labeling Claim". This is a medical device (examination glove) and the testing performed is for product specifications and biocompatibility, not for a diagnostic AI algorithm. Therefore, many of the requested categories (sample size for test/training sets, experts for ground truth, adjudication, MRMC studies, standalone performance, data provenance) are not applicable in this context.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for each test, but the methods are based on ASTM standards (e.g., AQL for pinholes), which involve specific sampling plans. For biocompatibility, "Rabbits" are mentioned for Primary Skin Irritation, implying a biological study with an animal test set.
• Data Provenance: Not explicitly stated, however, the testing is performed to meet US standards (ASTM) for FDA clearance. The document is a 510(k) summary submitted to the FDA in the USA.

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

• Not applicable as this is a device performance test based on laboratory measurements and biological reactions, not expert interpretation of data.

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

• Not applicable. The tests involve quantifiable measurements against established 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 an AI device.

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

• Not applicable. This is not an AI algorithm. The device itself (the glove) is the "standalone" component being tested for its physical, chemical, and biological properties.

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

• The "ground truth" here is defined by objective, measurable criteria established by recognized national and international standards (ASTM). For example, a glove either meets the specified AQL for pinholes or it does not, based on the statistical sampling plan and water leak test. For protein level, it's a quantitative measurement of protein content verified against a threshold. For biocompatibility, it's the observed biological response (or lack thereof) in test subjects.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Yellow, Red, Green, Black, Blue with Pearlescent™ Pigment, Powder-Free Nitrile Examination Gloves with Aloe Vera

The provided document is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. Therefore, I cannot generate the requested table and study description.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is for over-the counter use.

Powder-Free Nitrile Examination Gloves, Black

The provided text is related to an FDA 510(k) clearance for "Powder-Free Nitrile Examination Gloves, Black." This document is a regulatory approval and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. For a Class I device like examination gloves, substantial equivalence is often demonstrated through adherence to recognized standards and manufacturing processes, rather than a clinical study with detailed performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions about test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment are all relevant to AI/ML device studies, which is not what this document describes.

In summary, the provided content is a regulatory clearance for a medical glove, not a technical study report for an AI/ML device. Therefore, the requested information elements related to AI/ML device performance and study design are not applicable or available in this document.

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A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250) This device is not intended to be used as a chemical barrier.

Textured Powder Free Nitrile Examination Gloves (Blue color) with SAP (Super Absorbent Polymer), Textured Powder Free Latex Examination (Natural color) with SAP (Super Absorbent Polymer)

I am sorry, but the provided text is a 510(k) clearance letter for medical examination gloves and does not contain information about acceptance criteria, study details, or device performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.

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 not present in the given document.

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