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Powder Free Nitrile Examination Glove, Violet Color is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Powder Free Nitrile Examination Gloves, Violet Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6913-00a Standard Specification for Nitrile Examination Gloves. They are violet in colour and are powder free.

The provided document is a 510(k) summary for POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR. This submission is for a medical device (examination gloves), not an AI/algorithm-driven device. Therefore, many of the requested elements for AI device evaluation are not applicable.

However, I can extract the information relevant to the acceptance criteria and the "study" (nonclinical tests) performed to demonstrate compliance for this type of device.

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

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, etc., per ASTM D 6913-00a). It states "Testing performed per ASTM D 6913-00a" and "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig."

• Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the requirements of the referenced ASTM standard and animal testing protocols.
• Data Provenance: Not explicitly stated as "country of origin," but the testing was performed for a Malaysian manufacturer, LATEXX MANUFACTURING SDN. BHD. The tests are non-clinical (laboratory and animal studies). Retrospective or prospective is not applicable in the context provided.

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

Not applicable for this type of device. "Ground truth" in the context of an AI device usually refers to expert-annotated data. For examination gloves, performance is assessed against established physical, chemical, and biological standards through laboratory and animal testing.

4. Adjudication method for the test set

Not applicable for this type of device. Performance is determined by standardized laboratory measurements and observations in animal models, not by human reader consensus on an "image" or "case."

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-driven device.

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

Not applicable. This is not an AI-driven device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on well-established industry standards and scientific methods:

• Standard Specifications: Adherence to ASTM D 6913-00a for physical and performance characteristics of examination gloves.
• Established Biological Tests: Results from standardized primary skin irritation tests (in rabbits) and delayed contact sensitization tests (in guinea pigs).
• Chemical Tests: Results from the USP iodine test for starch.

8. The sample size for the training set

Not applicable. This is not an AI-driven device requiring a training set.

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

Not applicable. This is not an AI-driven device.

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Powder Free Nitrile Examination Glove, Blue Color is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are blue in colour and are powder free.

The provided text is for a 510(k) summary for "NON-CHLORINATED, POLYMER COATED, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE COLOR". This document describes the device and its compliance with established standards, but it does not contain information related to an AI/ML device. Therefore, many of the requested points regarding AI/ML device performance and testing (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) are not applicable.

Here's an analysis based on the information provided for the nitrile examination gloves:

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

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

The document does not specify exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, number of animals for biocompatibility). The provenance of the data is that the tests were performed by the manufacturer, LATEXX MANUFACTURING SDN. BHD., based in Malaysia. The studies were non-clinical (laboratory and animal-based) and are presented as retrospective data to support 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 is not applicable as this is a non-AI/ML device submission for examination gloves. The "ground truth" is established by the specifications defined in ASTM D 6319-00a and 21 CFR 800.20, which are consensus standards and regulations.

4. Adjudication method for the test set

Not applicable for this type of device and testing. Test results are compared directly against established standard specifications.

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/ML device.

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

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

7. The type of ground truth used

The ground truth is based on established industry standards and regulatory requirements, specifically:

• ASTM D 6319-00a (Standard Specification for Nitrile Examination Gloves for Medical Application)
• 21 CFR 800.20 (Pinhole Barrier Integrity)
• USP iodine test (for absence of starch)
• Standard methods for biocompatibility testing (skin irritation and sensitization in animal models).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

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

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QTEXX, Non - Chlorinated Powder free Nitrile Examination Glove, polymer-coated is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

QTEXX, Non - Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 – 99, Standard Specification for Rubber Examination Gloves, They are blue or natural white in colour and are powder free.

Here's a breakdown of the acceptance criteria and study information for the QTEXX Non-Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-Coated, based on the provided document:

This document is a 510(k) submission for a medical device (nitrile examination gloves) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for an AI/algorithm-driven device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, direct effect sizes for AI improvement) are not applicable to this type of regulatory submission for a physical medical glove. The "device" in this context is the glove itself, not an AI or software algorithm.

However, I can extract the relevant information regarding performance criteria and the studies conducted to meet them as presented in the document.

Acceptance Criteria and Reported Device Performance

Note: The document states that the device is "substantially equivalent to the Class 1 patient examination glove 80LZA. It meets all the current specifications listed under the ASTM Specification D 3578 – 99, Standard Specification for Rubber Examination Gloves". The table above extracts the implicit and explicit criteria mentioned.

Study Details (as applicable to a physical medical device)

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

   • The document does not specify the exact sample sizes used for the nonclinical tests (e.g., how many gloves were tested for physical properties, how many rabbits/guinea pigs were used). This level of detail is typically found in the full study reports, not the summary K992924 submission.
   • Data Provenance: The origin of the data is from testing conducted by the manufacturer, Latexx Partners Berhad, likely in Malaysia, to meet U.S. regulatory standards (ASTM and FDA). This would be considered prospective testing specifically for this device.

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

   • Not Applicable. This question typically pertains to studies involving human interpretation (e.g., medical imaging, clinical assessments) where expert consensus establishes a "ground truth" for an algorithm. For physical device testing like gloves, "ground truth" is established by standard laboratory measurements and observations against predefined criteria.

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

   • Not Applicable. As above, this is for clinical interpretation studies. Laboratory testing results are typically directly measured and compared to specifications.

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:

   • Not Applicable. No MRMC study was conducted or is relevant for this physical device. This question applies to AI-assisted diagnostic or interpretive tasks.

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

   • Not Applicable. This applies to AI/software performance. The performance described here is for the physical glove itself.

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

   • Objective Measurement against Standards: The "ground truth" for the physical properties of the gloves (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM D 3578-99 standard specifications.
   • Observed Biological Response: For biocompatibility, the "ground truth" is the observed biological response (lack of irritation or sensitization) in the animal models, as per established toxicology testing protocols.
   • Chemical Reaction: For powder-free status, the "ground truth" is the absence of a positive chemical reaction (USP iodine test).

7. The sample size for the training set:

   • Not Applicable. This question refers to machine learning algorithms. The manufacturing process of the gloves might involve internal quality control data, but there is no "training set" in the AI sense for establishing the glove's core performance.

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

   • Not Applicable. As per point 7.

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QTEXX Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

QTEXX Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are blue or natural white in colour.

Here's an analysis of the provided text regarding the QTEXX Pre-Powdered Nitrile Examination Gloves, broken down into the requested categories. Please note that the document is a 510(k) summary for a medical glove, which is a low-risk device. As such, the types of studies and information typically found for higher-risk diagnostic or AI-driven devices are not present.

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

For medical gloves, "acceptance criteria" are typically the standards and specifications they must meet. In this case, the primary standard is ASTM D 3578-99.

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

• Sample Size for Test Set: This information is not explicitly provided in the summary. For non-clinical tests like those specified in ASTM D 3578-99, specific sampling plans are typically outlined within the standard itself.
• Data Provenance: The tests were performed by the manufacturer, LATEXX PARTNERS BERHAD, located in Kamunting, Perak, Malaysia. The testing is non-clinical/laboratory-based.

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 for a medical glove submission. "Ground truth" in the context of medical gloves refers to objective physical and chemical testing against established standards (ASTM, FDA regulations) as well as animal model biocompatibility tests, not expert interpretation of diagnostic data.

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

This is not applicable for a medical glove submission. Adjudication methods are typically used in clinical studies or for subjective assessments (e.g., image interpretation), not for standardized physical property testing of manufactured goods.

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 for a medical glove submission. MRMC studies are used for diagnostic devices, particularly those involving human interpretation of data, often in conjunction with AI. This is a low-risk medical device (examination glove) where AI assistance or human reader performance improvement is not relevant.

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

This is not applicable. This device is a physical medical product, not an algorithm or AI system.

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

The "ground truth" for medical gloves is established by:

• Established Industry Standards: Primarily ASTM D 3578-99, which defines the physical and performance requirements (e.g., tensile strength, elongation, barrier properties, freedom from holes).
• Regulatory Requirements: 21 CFR 800.20, which deals with specific performance characteristics like freedom from holes.
• Biocompatibility Testing: Animal models (rabbit for primary skin irritation, guinea pig for delayed contact sensitization) provide objective data on biological response.
• Chemical Testing: USP iodine test for starch presence.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a manufactured medical glove. The product's design and manufacturing process are developed to meet the specified standards, not "trained" on data.

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

This is not applicable. As there is no training set, there is no ground truth for it.

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QTEXX Powder free Latex Examination Glove, polymer-coated is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

QTEXX Powder Free Latex Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves, They are natural white in colour and are powder free.

The provided text is related to a 510(k) submission for QTEXX Powder Free Latex Examination Gloves. This device is a medical glove, and the acceptance criteria and study design described are for demonstrating its physical and biocompatibility properties, rather than diagnostic performance metrics typically associated with AI/ML devices. As such, many of the requested fields (e.g., effect size of human readers, training set details) are not applicable.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify the exact sample sizes for each test performed under ASTM D 3578-95 or for the biocompatibility tests (skin irritation, sensitization). However, the tests are performed on the device itself.

• Data Provenance: The tests were conducted by the manufacturer, Latexx Partners Berhad, based in Malaysia. The testing is non-clinical/bench testing and animal studies.

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

This question is not applicable as the device is a physical medical glove and not an AI/ML imaging device that requires expert ground truth for diagnostic accuracy. The "ground truth" for these tests comes from established international standards (ASTM) and regulatory requirements (21 CFR). Biocompatibility tests are performed on animals.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established physical and chemical standards, and animal responses to the material. No human adjudication of diagnostic output is involved.

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/ML diagnostic device.

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

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

7. The type of ground truth used

The ground truth used for this device's performance validation is a combination of:

• Standard Specifications: ASTM (American Society for Testing and Materials) D 3578-95 for physical properties (e.g., tensile strength, elongation, barrier integrity).
• Regulatory Requirements: 21 CFR 800.20 for general medical device quality.
• Biocompatibility Testing: In vivo animal studies (rabbits for skin irritation, guinea pigs for sensitization) for biological safety.
• Chemical Testing: USP iodine test for starch presence, and methods for determining total water extractable protein.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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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QTEXX Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

QTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.

The provided text describes the acceptance criteria and the study for "QTEXX POWDER FREE LATEX EXAMINATION GLOVES". 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 within ASTM D 3578-95 or for the biocompatibility tests (skin irritation, sensitization). It states that "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20", which implies the manufacturer followed the sampling guidelines stipulated in those standards.

• Data Provenance: The document states "Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatibility requirements." This indicates that the testing was conducted in a laboratory setting (likely by the manufacturer or a contracted lab) and involved animal models. The country of origin for the data is not explicitly stated but can be inferred as Malaysia, where the manufacturer is located. The tests are prospective as they were conducted to demonstrate compliance for this specific device.

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

This section is not applicable in the context of device performance testing for examination gloves. The "ground truth" for these types of devices is established by objective measurements against established engineering and material standards (ASTM D 3578-95) and regulatory requirements (21 CFR 800.20, biocompatibility guidelines). There are no human expert interpretations required for parameters like glove dimensions, tensile strength, or protein content.

4. Adjudication Method for the Test Set

This is not applicable for this type of device testing. Adjudication methods (like 2+1, 3+1) are typically used for studies involving subjective interpretations, such as medical image analysis, where multiple experts might disagree. For physical device performance, the results are objective measurements.

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 device is a latex examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are irrelevant.

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

This is not applicable. This device is not an algorithm or software. It is a physical medical device (examination glove).

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

The ground truth for this device is based on objective, verifiable standards and laboratory measurements:

• ASTM D 3578-95: This standard defines the physical and performance requirements for rubber examination gloves (e.g., dimensions, tensile strength, elongation, watertightness).
• Biocompatibility Testing: Standards for primary skin irritation (e.g., ISO 10993-10) and sensitization (e.g., ISO 10993-10) using animal models, which involve objective assessment of tissue reactions.
• Chemical Testing: USP iodine test for starch and an unspecified method for total water extractable protein.

8. The Sample Size for the Training Set

This is not applicable. This device is 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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Proflex Powderfree Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

PROFLEX* Powder Free Nitrile Examination Gloves meet the current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves, EXCEPT for tensile strength and ultimate elongation requirement. They are blue or natural white in colour and are powder free.

Here's a breakdown of the acceptance criteria and the study information for the PROFLEX* POWDER FREE NITRILE EXAMINATION GLOVES, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (examination gloves). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing against established standards. It does not typically involve clinical studies with human participants in the way that, for example, an AI diagnostic device would. Therefore, many of the requested fields related to human readers, experts, ground truth for AI, etc., are not applicable to this type of device and submission.

1. Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on compliance with established industry standards for examination gloves.

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

• Sample Size: Not explicitly stated in the provided text. Testing was performed "per ASTM D 3578-95 (also per current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application) and 21 CFR 800.20." These standards typically define sampling plans for testing.
• Data Provenance: Not specified. The testing was conducted by the manufacturer, Latex Partners Bhd. (Malaysia). The tests are non-clinical (laboratory and animal studies).

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

• Not Applicable. This is a non-clinical device performance study. Ground truth is established by objective measurements against specified standard criteria (e.g., physical properties, chemical tests).

4. Adjudication Method for the Test Set

• Not Applicable. This is a non-clinical device performance study. Test results are compared directly to the specified criteria in the 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

• No. This type of study is entirely irrelevant for an examination glove. This is a non-clinical device.

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

• No. This is a non-clinical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Standard Specifications and Objective Measurements: For the physical properties (e.g., dimensions, freedom from holes), chemical properties (e.g., starch presence), and biological safety (skin irritation, sensitization), the "ground truth" is established by the specified requirements in the ASTM standards and the results of laboratory tests (e.g., animal studies for biocompatibility).

8. The Sample Size for the Training Set

• Not Applicable. This is a non-clinical device, not an AI algorithm requiring a training set.

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

• Not Applicable. This is a non-clinical device, not an AI algorithm.

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