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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera

The provided document is a 510(k) premarket notification letter from the FDA regarding "Aurella Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera." This document is a regulatory approval for a medical device (gloves) and does not contain information about software or AI-powered devices, nor does it detail a study with acceptance criteria and performance metrics in the way a clinical validation study for such a device would.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI-powered device from this document. The document primarily focuses on FDA's determination of substantial equivalence for a physical medical product (gloves) to legally marketed predicate devices.

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A powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

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This document describes the FDA's decision to allow the marketing of "Green Peppermint Flavored Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less)". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter assesses substantial equivalence of the gloves to previously marketed devices, which is a regulatory standard, not a performance study as would be conducted for a new diagnostic or therapeutic AI device.

Therefore, I cannot provide the requested information based on the provided text. The document is an FDA 510(k) clearance letter for examination gloves, which falls under general controls and does not involve AI or complex performance studies like those relevant to the questions asked.

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A powdered patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES

This document is a 510(k) clearance letter from the FDA for "Green Peppermint Flavored Powdered Latex Examination Gloves." This letter primarily addresses regulatory approval and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The information provided (e.g., FDA logo, communication regarding a 510(k) notification, product name, indications for use) is typical of a regulatory clearance for a medical device that is a physical product (gloves in this case), not a software or AI/ML device.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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A nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

POWDER FREE NITRILE EXAMINATION GLOVES

The provided document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves" (K993258). It does not contain sections detailing acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.

This document is from 1999 and pertains to a physical medical device (gloves), not an AI/ML powered device. Therefore, the requested information categories are not applicable to the content of this document.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." [50 Microgram or less Protein labeling Claim]

Polymer Coated Powder Free Latex Examination Gloves

This document is a 510(k) premarket notification letter from the FDA regarding "Latex Examination Gloves (50 mcg or less protein labeling claim)". It concerns the regulatory approval of a medical device, which is a type of glove, and does not involve AI or an algorithm. Therefore, none of the requested information about AI device acceptance criteria, study data, ground truth, or MRMC studies is applicable to this document.

The document primarily states that the device is substantially equivalent to legally marketed devices and can be marketed subject to general controls. It details the product name, applicant, 510(k) number, and indications for use, which are as follows:

Indications For Use: "A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." with a "[50 Microgram or less Protein labeling Claim]".

The document does not contain information on device performance metrics, study designs, sample sizes, or expert qualifications as it is a regulatory approval letter based on substantial equivalence, not a performance study report for an AI device.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Powdered Nitrile Examination Gloves

The provided text is a 510(k) Pre-market Notification from the FDA concerning "Powdered Nitrile Examination Gloves." This type of document is a regulatory approval for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/diagnostic devices.

Here's why and what information can be extracted:

• Device Type: Examination gloves are Class I medical devices (Product Code: LZA). For these devices, the regulatory pathway (510(k)) primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market.
• No Performance Study Details: The letter acknowledges the submission and states that the device is "substantially equivalent." It doesn't present technical performance metrics, sensitivity, specificity, or reader studies because these are not typically required for this class of device or at this stage of the 510(k) process for a physical, low-risk product like a glove. The "study" mentioned would have been internal testing by the manufacturer to show the glove meets its intended purpose (e.g., integrity, strength, biocompatibility), but the details of that study are not in this FDA letter.
• "Acceptance Criteria" for a Glove: For gloves, "acceptance criteria" likely refer to standards for tensile strength, elongation, puncture resistance, barrier properties, freedom from holes, and biocompatibility, as outlined in recognized industry standards (e.g., ASTM D6319 for nitrile examination gloves). The letter implies that Supermax Glove Manufacturing Sdn. Bhd. provided data demonstrating compliance with these types of standards in their original 510(k) submission, leading to the substantial equivalence determination.

Therefore, I cannot fill out your requested table and study details based on the provided document.

Here’s an explanation of why each of your requested points cannot be addressed by this document:

1. A table of acceptance criteria and the reported device performance: Not present. The letter confirms "substantial equivalence" but doesn't list specific performance metrics.
2. Sample size used for the test set and the data provenance: Not present. This information would be in the manufacturer's submission, not the FDA's approval letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This concept (experts establishing ground truth) is more relevant to diagnostic interpretations, not physical product testing for gloves.
4. Adjudication method: Not applicable/present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/present. This is for diagnostic interpretation, not product physical properties.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/present. This is for AI/software, not a physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/present in this context. For gloves, 'ground truth' would be objective physical and chemical test results based on established standards.
8. The sample size for the training set: Not applicable/present. This refers to AI model training.
9. How the ground truth for the training set was established: Not applicable/present.

In summary, this document is a regulatory approval for a low-risk medical device (exam gloves) based on substantial equivalence, and it does not contain the detailed performance study information typically required for high-risk diagnostic devices or AI algorithms.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Latex powdered patient examination gloves with 70 mcgm or less of total water extractable protein per gram

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for "Supergloves, Latex Powdered Exam Gloves" and an "Indications for Use" statement.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It does not include performance data, study designs, sample sizes, or information about expert ground truth determination. The "Indications For Use" section simply states the purpose of the medical examination glove.

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