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Xingyu Powder Free Nittile Patient Examination Gloves, White Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner

Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).

The document describes the conformity of the Xingyu Nitrile Powder Free Patient Examination Gloves, White color to established standards for patient examination gloves. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, many of the requested elements (multi-reader multi-case study, AI-related information, expert qualifications, adjudication methods) are not applicable.

Here's the information that can be extracted and formatted based on the provided document:

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 (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It generally refers to "bench testing."
• Data Provenance: The tests were conducted by Shandong Xingyu Gloves Co., Ltd (China). The data implicitly comes from internal testing by the manufacturer. It is retrospective as it was completed before the 510(k) submission.

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

• Not applicable. This is not a study involving ground truth established by human experts. The "ground truth" for these tests are the established ASTM and ISO standards for glove performance.

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

• Not applicable. There was no expert adjudication process for these types of physical and chemical tests. The results are based on objective measurements against defined 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 document is for patient examination gloves, not an AI or imaging device, and therefore no MRMC study was performed.

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

• Not applicable. This document is for patient examination gloves, not an AI or algorithm-based device.

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

• The "ground truth" for the device's performance is objective measurement against pre-defined performance standards and regulatory requirements (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10, and 21 CFR 800.20 related to pinholes).

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device that requires a training set.

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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) premarket notification for Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color. It describes the device, its intended use, and a study to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided text describes the acceptance criteria and performance data for the "Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color." This is a medical device, and the information is presented in the context of a 510(k) premarket notification for demonstrating substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and reported device performance:

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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

This document describes the acceptance criteria and performance of the "Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color" (K152720) in comparison to a predicate device (K120970) to establish substantial equivalence for FDA 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance:

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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) summary for the Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested fields are not applicable to the context of this document.

Here's the information that can be extracted from the provided text, formatted to address your request:

Acceptance Criteria and Device Performance

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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document describes a 510(k) premarket notification for "Nitrile Powder Free Patient Examination Gloves, Blue Color," which is a Class I medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than describing a study to prove performance against acceptance criteria for an AI/ML powered device.

Therefore, many of the requested fields are not applicable to this document. I will extract the available information and indicate where information is not present or not relevant to an AI/ML context.

1. Table of Acceptance Criteria and Reported Device Performance

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Nitrile Powder Free Patient Examination Gloves, Blue color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) summary for Nitrile Powder Free Patient Examination Gloves, Blue Color. This document describes the device's characteristics and its comparison to a predicate device to establish substantial equivalence, not a study performing extensive clinical trials typically associated with AI/ML devices. Therefore, many of the requested criteria regarding AI device performance are not applicable to this submission.

Here's an analysis of the provided information relative to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting established ASTM and CFR standards.

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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document describes the acceptance criteria and performance of the Nitrile Powder Free Patient Examination Gloves, Blue Color based on non-clinical performance data, as clinical data was not deemed necessary for this device.

Here's the breakdown of the information requested:

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

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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nitrile Powder Free Patient Examination Gloves, Blue Color:

1. Table of Acceptance Criteria and Reported Device Performance

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Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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 Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10

This document is a 510(k) summary for a medical device called "Powder Free Nitrile Patient Examination Gloves, Blue Color." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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