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A powder free nitrile 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 tested chemotherapy drugs and their breakthrough detection time are as follows :

Please note that the following drugs have low permeation times: Carmustine - 60.2 minutes Thiothepa - 105.6 minutes

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Blue Nitrile Examination Gloves Tested With Chemotherapy Drugs". It primarily focuses on the regulatory approval process and includes a table of chemotherapy drug breakthrough times. This document does not describe the acceptance criteria of a device nor a study that proves the device meets those criteria in the context of an AI/medical imaging or diagnostic device.

The information requested in the prompt (sample size for test/training sets, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, etc.) is relevant for the evaluation of AI/diagnostic devices, not for examination gloves.

Therefore,Based on the provided document, the requested information about acceptance criteria and a study proving a device meets those criteria cannot be extracted. The document is a 510(k) premarket notification for "Powder Free Blue Nitrile Examination Gloves Tested With Chemotherapy Drugs" and pertains to regulatory clearance, not a study evaluating an AI/diagnostic device against specific performance acceptance criteria.

The only "performance" reported is related to the breakthrough detection time of chemotherapy drugs through the glove, which is a chemical resistance test, not a measure of diagnostic accuracy or AI performance.

Therefore, I cannot populate the table or answer the specific questions as they relate to a different type of device evaluation (e.g., AI in medical imaging) than what is presented in the document.

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A powder-free latex 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.

Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2

The provided text is a clearance letter from the FDA for a medical device: "Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm-".

This document does not describe an AI/ML powered device or a study with acceptance criteria and performance as would be expected for such a device. Instead, it's a 510(k) premarket notification clearance letter for a patient examination glove. The "study" mentioned within the document relates to the glove's resistance to chemotherapy drugs.

Therefore, the requested information elements related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this document.

However, I can extract information related to the performance claims made for the glove regarding chemotherapy drug resistance.

Here's the relevant information that can be extracted:

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

The document presents the breakthrough detection time (BDT) for various chemotherapy drugs when tested with the gloves. While explicit "acceptance criteria" for BDT are not stated in this document (it's often referenced against national or international standards, which are not detailed here), the reported performance is the BDT in minutes. The implication is that a longer BDT is better.

Note: The document also explicitly highlights:

• White Latex Powder Free: Carmustine - 15.2 minutes, Thiotepa - 15.2 Minutes
• Blue Latex Powder Free: Carmustine - 5.7 minutes, Thiotepa - 16.4 minutes

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: Not specified in the provided text for the chemotherapy drug resistance testing.
• Data Provenance: Not specified in the provided text. The manufacturer is based in Malaysia. The testing data would typically be generated in a lab.

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)

• Not applicable. This is not an AI/ML device requiring expert ground truth in the diagnostic sense. The "ground truth" for glove performance is determined by laboratory testing protocols for chemical resistance.

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

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

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. The "device performance" relies on physical testing against chemicals.

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

• The "ground truth" for the chemotherapy drug resistance is established through laboratory testing methodologies that measure the time it takes for a chemical to permeate the glove material (Breakthrough Detection Time). This is a direct physical measurement, not an expert assessment of a medical condition.

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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A powder free latex examination glove with vanilla, grape and strawberry flavor 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.

Flavoured, Powder Free And Polymer Coated Latex Examination Glove (Vanilla, Grape and Strawberry) With A Protein Claim Of Less Than 50ug/dm2

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance. The document is a 510(k) premarket notification from the FDA regarding "Flavored, Powder Free and Polymer Coated Latex Examination Glove". It primarily focuses on regulatory approval and substantial equivalence to existing devices, and does not include details on acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML powered medical device.

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A powder free nitrile 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.

Colored Powder Free And Polymer Coated Nitrile Examination Glove (White, Blue and Black)

This document is a 510(k) summary for a Nitrile Examination Glove. It is a regulatory clearance letter from the FDA, and as such, it does not contain the kind of detailed study information you are asking for (acceptance criteria for algorithmic performance, sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).

The purpose of a 510(k) submission for this type of Class I medical device (patient examination glove) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance metrics through detailed studies. The acceptance criteria for such a device would typically relate to physical properties (e.g., tensile strength, elongation, barrier integrity like pinhole rate) and biocompatibility, as well as labeling requirements. These are usually established through recognized consensus standards rather than clinical performance studies of an algorithm.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory classification and clearance.

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A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.

A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.

The provided text is related to an FDA 510(k) premarket notification for a medical device: "Colored Powder Free and Polymer Coated Latex Examination Glove (Blue, Black and Pink) with a Protein Claim of Less than 50 ug/gm Glove".

This document is an FDA clearance letter, not a study report or a summary of acceptance criteria and performance data for a device. It confirms that the device is substantially equivalent to a legally marketed predicate device. Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not present in the provided text.

The document states the "Indications For Use" for the glove:
"A colored, powder free and polymer-coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove."

The primary performance claim highlighted is "with a Protein Claim of Less than 50 ug/gm Glove." However, the document does not detail the specific test methods, acceptance criteria, or the study results that demonstrate this claim. Such information would typically be found in the 510(k) submission itself, not the FDA's clearance letter.

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

Tekmedic Powder-Free Latex Patient Examination Gloves with Aloe Vera Coating and Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram

This document is a 510(k) premarket notification decision letter from the FDA regarding "Tekmedic Powder-Free Aloe Care Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." This type of document is a regulatory approval and does not describe a study that validates the performance of a device against acceptance criteria for algorithm-based medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval in this context.

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

Tekmedic Powder-Free Latex Examination Gloves, with Protein Labeling Claim (50 Micrograms or Less)

The provided text describes a 510(k) premarket notification for "Tekmedic Powder-Free Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less)." This document is a regulatory approval, not a scientific study describing acceptance criteria and device performance.

Therefore, I cannot provide the requested information as the input does not contain a study detailing acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies. The document is solely an FDA approval letter based on substantial equivalence to a predicate device.

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

Tekmedic Powder-Free LATEX Examination Gloves

This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving device performance as typically expected for complex medical devices like AI algorithms or diagnostic tools. The content focuses on regulatory compliance for a Class I medical device (Powder-Free Latex Patient Examination Gloves).

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or expert qualifications because it is not present in the provided text.

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