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MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.

The provided text describes the acceptance criteria and the study results for the MOTEX Polyisoprene Powder-free Sterile Surgical Gloves. It is a 510(k) submission, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in the context of an AI/ML medical device. However, I can reframe the information to fit the requested table and provide a "study" description based on the non-clinical tests performed to show substantial equivalence.

Here's the breakdown of the information as requested, adapted for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Motex Powdered Nitrile Surgical Gloves are made of synthetic rubber. They are sterilized by radiation, and intended to be used in surgery to prevent the cross contamination between patient and user.

This is a medical device submission for a surgical glove, not an AI/ML powered device. As such, the requested information regarding AI/ML study design and performance criteria is not applicable.

The device, Motex Powdered Nitrile Surgical Gloves, is seeking substantial equivalence to a predicate device (NUZONE Nitrile Powdered Surgical Gloves) based on meeting established performance standards for surgical gloves.

Here's a breakdown of the requested information, adapted for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance

This device's performance is demonstrated by meeting recognized industry standards.

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

The document specifies performance testing against ASTM and ISO standards. These standards typically specify their own sampling plans and test methodologies. The document does not provide the specific sample sizes used for each test (e.g., number of gloves tested for pinholes, physical properties).

• Data Provenance: The tests were conducted by the manufacturer, Shanghai Motex Healthcare Co., Ltd. (China). The document does not explicitly state whether the tests were retrospective or prospective, but based on the context of a 510(k) submission, they would typically be prospective tests performed on representative samples of the manufactured devices to demonstrate compliance with standards.

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

This is not applicable for this type of medical device. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) often associated with AI/ML systems. For surgical gloves, compliance with physical, chemical, and biological standards is determined by laboratory testing and measurements, not by expert consensus on an "answer."

4. Adjudication method for the test set

Not applicable for this type of medical device. Adjudication methods like 2+1 or 3+1 refer to how multiple expert opinions are resolved to establish a single "ground truth," which is not relevant for objective laboratory measurements against predefined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this was not done. MRMC studies are specific to evaluating the diagnostic performance of readers (human or AI) on cases, particularly in imaging, and are not relevant for the evaluation of a surgical glove's physical and biological properties. There is no "human reader" component in assessing a surgical glove's compliance with ASTM/ISO standards.

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

Not applicable. This device is a surgical glove, not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies here.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective, quantitative measurements and laboratory tests defined within internationally recognized standards (ASTM, ISO). For example:

• Physical properties (e.g., tensile strength, elongation): Measured values are compared against minimum/maximum thresholds specified in ASTM D3577-09.
• Freedom from holes: Determined by water leak testing (ASTM D5151-06), where the "ground truth" is whether a glove leaks or not under specified pressure for a given duration.
• Residual powder: Measured directly and compared against the 15mg/dm² threshold from ASTM D6124-06.
• Biocompatibility: Determined by the results of specific in-vitro and in-vivo tests (e.g., skin irritation, sensitization) that follow ISO 10993 series standards, where the "ground truth" is the observation of a biological response (or lack thereof) compared to control or reference materials.
• Sterilization: Validated by adherence to ISO 11137 series standards, ensuring a specified sterility assurance level (SAL).

8. The sample size for the training set

Not applicable. This device is not an AI/ML system, so there is no concept of a "training set" in the machine learning sense. The device is manufactured according to specifications and then tested against standards, not "trained" on data.

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

Not applicable for the same reasons as #8.

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A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Motex Powder-free Nitrile Surgical Gloves are made of synthetic rubber. Thev are sterilized by radiation, and intended for be used in surgery for patient and user.

The provided document describes the acceptance criteria and a study to demonstrate the substantial equivalence of the "Motex Powder-free Nitrile Surgical Gloves" to a predicate device, focusing on safety and effectiveness.

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 the data provenance:

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., number of gloves tested for dimensions, holes, powder). The studies are primarily laboratory-based performance tests against established standards. The provenance of the data is from Shanghai, China, where the manufacturer (Shanghai Motex Healthcare Co., Ltd.) is located. These are likely retrospective tests conducted on manufactured batches to ensure compliance with the standards.

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 in the context of this device. The "ground truth" for these types of medical devices is established by adherence to internationally recognized consensus standards (ASTM, ISO). These standards define the acceptable range or threshold for each characteristic, and laboratories perform tests to measure these characteristics against those predefined limits. There isn't a team of experts adjudicating individual glove results in the same way a medical image might be reviewed.

4. Adjudication method for the test set:

This is not applicable. As mentioned above, the assessment is against established objective technical standards, not subjective expert judgment that would require 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:

This is not applicable. This document describes a surgical glove, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance assessment was conducted.

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 device (surgical glove), not a software algorithm.

7. The type of ground truth used:

The ground truth used is based on established industrial and medical device standards (ASTM, ISO). These standards define the limits and methodologies for testing physical properties, safety (biocompatibility), and sterility of surgical gloves.

8. The sample size for the training set:

This information is not applicable. This product is a physical device, not an AI or machine learning model that requires a "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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Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder).

Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning.

The characteristics are summarized below compared to ASTM and ISO standards to the predicate device:
Characteristic: Dimensions, Standard: meets ASTM D 3577-06,
Characteristic: Physical Properties, Standard: meets ASTM D 3577-06,
Characteristic: Freedom from Holes, Standard: meets ASTM D 3577-06,
Characteristic: Biocompatibility, Standard: meets ISO10993-5/-10
Characteristic: Sterilization Validation, Standard: meets ISO11137

The acceptance criteria and device performance are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for each specific test (e.g., dimensions, physical properties). It indicates that the device characteristics were "summarized below compared to ASTM and ISO standards." This implies that the testing was conducted in accordance with the methodologies and sample sizes specified within those respective standards.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (compliance with manufacturing and safety standards), it's highly likely they were prospective tests conducted on manufactured glove samples.

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

This information is not provided. For device testing against technical standards like ASTM and ISO, "ground truth" is established by the specifications defined in those standards, and the assessment is typically performed by trained technicians or laboratory personnel rather than clinical "experts" in the context of medical image analysis or disease diagnosis.

4. Adjudication Method for the Test Set:

This information is not provided. For standardized testing, adjudication in the sense of expert consensus on ambiguous cases is generally not applicable; rather, measurements are taken and compared directly against specified tolerances within 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:

This type of study was not applicable and therefore not conducted. The device in question is surgical gloves, a barrier device, not an AI-powered diagnostic or assistive tool for human readers.

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

This type of study was not applicable and therefore not conducted. The device is a physical barrier device, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is derived from established industry standards and specifications. Specifically:

• ASTM D 3577-06: Standard Specification for Rubber Surgical Gloves. This standard dictates requirements for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
• ISO 10993-5/-10: Biological evaluation of medical devices. Part 5 addresses tests for in vitro cytotoxicity, and Part 10 addresses tests for irritation and skin sensitization.
• ISO 11137: Sterilization of health care products — Radiation. This standard specifies requirements for the development, validation, and routine control of a sterilization process.
• Specific limits for powder and extractable protein content: These are direct measurements compared against specified maximum thresholds.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical product (surgical gloves), not an AI model that requires a training set.

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

This information is not applicable for the same reason as above (not an AI model).

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This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).

Nitrile rubber is impermeable to water and body fluids under normal conditions of use. The physical properties of the nitrile rubber enable it to conform to the hand for medical procedures. Nitrile rubber is known to form a superior barrier to bloodborne pathogens and meet physical properties for medical examination procedures as specified in ASTM D6319-00ae3.

This document is a 510(k) submission for Green Powder-Free Nitrile Examination Gloves, identifying K041276 as the submission number. The submission outlines the device's characteristics, intended use, and a comparison to a predicate device (K030207). It includes performance data from non-clinical tests to demonstrate safety and effectiveness.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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 for the non-clinical tests (e.g., number of gloves tested for freedom from holes or physical properties). Similarly, the country of origin for the data is not specified beyond the submitter's location in Shanghai, China. The studies described are non-clinical (laboratory testing), not human clinical trials, so the terms "retrospective" or "prospective" are not applicable in the typical sense for patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The ground truth for these non-clinical tests is established by adherence to recognized international and national standards (ASTM, FDA, ISO) and the results obtained from standardized testing methods. There is no mention of expert consensus establishing ground truth for these specific performance characteristics.

4. Adjudication Method:

Not applicable. This is not a study involving human readers or interpretations needing adjudication. The results are based on objective measurements and adherence to specified pass/fail criteria within the standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved, which is not the case for examination gloves.

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

Yes, in a sense, the tests performed are "standalone" in that they evaluate the physical and biological properties of the glove itself against established standards, without human interaction in a diagnostic or interpretive loop. The device's performance is determined solely by its material properties and manufacturing quality as measured by the specified tests.

7. The Type of Ground Truth Used:

The ground truth used for these tests is defined by:

• Established Standards: ASTM D6319-00ae3, ASTM D5151-99, ASTM D6124-01, FDA 21 CFR 800.20, and ISO 10993 Part 10. These standards set the criteria for acceptable performance (e.g., maximum allowable holes, maximum powder residue, minimum physical properties like tensile strength).
• Experimental Results: The outcome of the tests (e.g., whether the glove "Meets" the standard, or "Passes" irritation tests) constitutes the evidence against these standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a medical glove, and the evaluation is based on non-clinical performance testing. It does not involve AI algorithms that require training sets of data.

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

Not applicable, as no training set for an AI algorithm is involved.

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Nitrile Powder-free Examination Glove, ProBlue is a disposable device made of synthetic materials intended for medical purposes that are worn on the examiner's hand or finger(s) to prevent contamination of potentially infectious materials between patient and examiner.

Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735

The provided text is a 510(k) premarket notification letter from the FDA regarding "Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735." This document outlines the FDA's determination of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for an AI/ML product.

The letter is for a physical medical glove and discusses regulatory compliance for manufacturing and marketing, not the performance metrics of a software or AI device. Therefore, I cannot generate the requested table and study information based on this document.

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It is a disposable device made of natural rubber latex material 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 potentially infectious materials and other contaminants.

disposable device made of natural rubber latex material that may bear a trace amount of glove powder

The provided text is a 510(k) premarket notification letter from the FDA regarding "MOTEX Powder-Free Examination Gloves with Protein Labeling Claim (300 Micrograms or Less)." This document is a regulatory approval for a medical device and does not contain any information about a study involving AI, algorithms, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide answers to the specific questions because the document describes a physical medical device (gloves) and its regulatory classification, not a software-based device or a study with acceptance criteria and performance metrics typically associated with AI/ML evaluations.

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Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

This document is a 510(k) premarket notification letter from the FDA regarding Motex Nitrile Examination Gloves Powder-Free. It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices or AI algorithms. Instead, it is a regulatory document affirming substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as this information is not present in the provided text.

The document only states the "Indications For Use" for the gloves: "Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner."

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