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The patient examination glove is a disposable device and is made of natural The patient exammation grove is a 'displace' worn on the examiner's hand of furoer to prevent contamination between patient and examiner.

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 and FDA 21 CFR 800.20.

The provided text describes a 510(k) summary for "Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim". This is a medical device application for examination gloves, which falls under a different category than typical AI/ML medical devices that require the types of studies listed in the prompt.

Therefore, many of the requested elements are not applicable to this 510(k) submission. Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 and FDA 21.CFR 800.20.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less)":

It's important to note that this 510(k) summary is for a medical device (gloves), not an AI algorithm. Therefore, many of the typical questions related to AI studies (like sample size for test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or training set details) are not applicable or not provided in this type of submission.

The document primarily focuses on demonstrating that the gloves meet established industry standards and regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) 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.

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01ε1 and FDA 21 CFR 800.20.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Device: Powder Free Latex Examination Glove, Sterile (Protein Content Labeling)

1. Table of Acceptance Criteria and Reported Device Performance:

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The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

Here's a breakdown of the acceptance criteria and study information for the "Dermagrip Powder Free Latex Examination Gloves" based on the provided 510(k) summary:

This device is a medical glove, and the studies performed are for validating performance characteristics against established ASTM (American Society for Testing and Materials) and FDA standards, not for evaluating an AI algorithm's diagnostic performance. Therefore, many of the requested categories related to AI studies (e.g., sample size for training, ground truth for training, MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable to this type of device and study.

Acceptance Criteria and Reported Device Performance

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

The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.

1. Acceptance Criteria and Device Performance:

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The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) is a disposable device intended for medical purposes that is worn by surgeon's and / or operating room personnel to protect a surgical wound from contamination.

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) meets all the requirements of ASTM Standard D 3577 - 00 and FDA 21 CFR 800.20.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.

The device in question is the "Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling)", which is a patient examination glove.

Acceptance Criteria and Device Performance:

The acceptance criteria for the glove are based on established ASTM standards and FDA regulations. The device's performance is reported to meet all these criteria.

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The Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile 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.

The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 00 and FDA 21 CFR 800.20.

The medical device in question is the "Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile." The study described is a non-clinical performance evaluation comparing the device's characteristics against established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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Ask a specific question about this device

Ask a specific question about this device