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The Nugard Black Powder Free Latex Examination Glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

The provided text is an FDA 510(k) clearance letter for a medical device: "Nugard Black Powder Free Latex Examination Glove, Polymer Coated."

This document is a regulatory clearance and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way one would describe for a diagnostic or algorithmic device. It's a clearance for a Class I medical device (patient examination glove), which typically relies on established performance standards for similar devices rather than novel clinical studies to demonstrate analytical or clinical performance.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to the information provided in this regulatory document.

However, I can extract the relevant information regarding the device's characteristics and the implied "acceptance criteria" for this type of device, which typically involves compliance with recognized standards.

Here's a breakdown based on the provided text, highlighting what is present and what is not:

1. Table of acceptance criteria and the reported device performance

Explanation: For Class I devices like examination gloves, the "acceptance criteria" are generally derived from recognized consensus standards (e.g., ASTM standards for medical gloves) that address physical properties, barrier integrity (e.g., freedom from holes), biocompatibility, and protein content for latex gloves. The document confirms that the device meets the description of these characteristics, which serves as the "reported device performance" in this context. The mention of "50 micrograms or less of water extractable protein" is a specific performance claim related to latex allergenicity, common for "low protein" latex gloves.

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

• Not Applicable / Not Provided in this document. The FDA 510(k) clearance letter does not detail the specific testing methodologies (like sample size or data provenance) used by the manufacturer to demonstrate compliance with performance standards for physical characteristics, barrier integrity, or protein content. This information would be within the manufacturer's 510(k) submission, not typically in the clearance letter itself.

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

• Not Applicable / Not Provided in this document. Ground truth establishment by experts is typically for diagnostic devices where subjective interpretation (e.g., imaging, pathology slides) is involved. For a physical device like a glove, "ground truth" relates to objective measurements against ASTM or ISO standards (e.g., tensile strength, dimensions, freedom from holes, protein assay results). These tests do not typically involve human expert consensus for interpreting results but rather adherence to validated laboratory methods.

4. Adjudication method for the test set

• Not Applicable / Not Provided in this document. Adjudication methods (like 2+1, 3+1) are relevant to studies where human readers are making subjective assessments that need to be resolved. This is not pertinent to the evaluation of a physical product like a glove, which is assessed through objective, standardized laboratory tests.

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. An MRMC study is relevant for diagnostic devices, particularly AI-powered ones, to assess the impact of AI on human reader performance. This device is a physical medical glove and does not involve AI or human interpretation in its function.

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

• Not Applicable. This device is a physical product, not an algorithm. Standalone performance refers to the performance of an AI algorithm independent of human interaction.

7. The type of ground truth used

• Implied Ground Truth: For physical characteristics (like dimensions, tensile strength) and chemical properties (like protein content, chemical integrity), the ground truth is established through objective laboratory measurements and validated assays performed according to recognized consensus standards (e.g., ASTM D3577 for latex examination gloves, or specific methods for protein content). The FDA's substantial equivalence determination implies these tests were conducted and met the relevant specifications for predicate devices.

8. The sample size for the training set

• Not Applicable / Not Provided in this document. Training sets are used in machine learning for AI algorithms. This device is a physical product.

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

• Not Applicable / Not Provided in this document. As with the training set itself, "ground truth" establishment for a training set is relevant to AI/ML development, which is not applicable here.

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The Powder Free Polychloroprene Examination Glove Blue or Pink, non sterile is a disposable device and is made of synthetic rubber intended for medial purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Polychloroprene Examination Glove Blue Powder Free Polychloroprene Examination Glove Pink

This document is a 510(k) premarket notification from the FDA for polychloroprene examination gloves. It is NOT a study about an AI/ML medical device. Therefore, it does not contain the information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, or details about comparative effectiveness studies.

The document pertains to a Class I medical device (patient examination glove), which is subject to general controls and does not typically require the rigorous clinical study details outlined in the prompt for AI/ML devices.

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The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This document is a marketing clearance letter from the FDA for a medical device: "Powder Free Polychloroprene Examination Glove Green". It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any AI-related studies.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls provisions. It specifies the regulation number (21 CFR 880.6250), regulation name (Patient Examination Glove), regulatory class (Class I), and product code (LZA). The "Indications for Use" section states that the glove is a disposable device made of synthetic rubber intended for medical purposes to prevent contamination between patient and examiner.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly for regulatory approval and does not delve into the performance evaluation metrics or study details typically associated with AI/medical device performance.

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The surgeon's gloves is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

SENSIFLEX PLUS Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less

The provided document is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about the acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria. The document is for a physical medical device (surgical gloves) and thus the requested information, which pertains to AI/SaMD, is not applicable.

Therefore, I cannot extract the requested information from this document.

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A surgeon's glove is a device made of natural or 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. (as per described in 21 CFR 878,4460)

SENSIFLEX PLUS Sterile Latex Surgical Gloves Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less

I am sorry, but based on the provided document, there is no information about acceptance criteria for a device, a study that proves the device meets specific acceptance criteria, or any of the detailed aspects requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

The document is an FDA 510(k) clearance letter for "SENSIFLEX PLUS Sterile Latex Surgical Gloves Powder Free with Protein Content Labeling Claim with 50ug/dm- or less." It primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include data from a clinical or performance study that would demonstrate the device's accuracy, sensitivity, specificity, or any other performance metrics typically associated with acceptance criteria for a diagnostic or AI-driven device.

The information provided is purely administrative regarding the regulatory clearance of a medical device (surgical gloves).

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This Surgeons Glove is a 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. These gloves are tested for use with Chemotherapy Drugs.

Polychloroprene Synthetic Tan Surgical gloves Powder Free

This document is a 510(k) clearance letter for a medical device, specifically the Nuzone X2T surgical gloves. The provided text primarily focuses on the regulatory approval and a table of chemotherapy drug permeation data. It does not describe an AI/ML device or its performance criteria in the typical sense of a diagnostic or predictive model.

Therefore, many of the requested categories are not applicable to this type of medical device clearance.

Here's the breakdown based on the provided information, addressing what is relevant and noting what is not:

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

The acceptance criteria for surgical gloves, as indicated by the reference to ASTM D6978-05 for chemotherapy drug testing, usually involve minimum breakthrough times for specific drug concentrations. The study demonstrates the device's performance against these criteria.

Note: The exact "acceptance criteria" for Carmustine and Thiotepa are not explicitly stated as a minimum threshold in the document, but rather the reported average breakthrough times are given. For the other drugs, "Up to 240 Minutes" is both the reported performance and implies that permeation did not occur within that timeframe, which is a common acceptance criterion for chemotherapy gloves. The phrasing "Please note that the following drugs have extremely low permeation times Carmustine (BCNU) of 5.18 and Thiotepa of 3.03 minutes" serves as a warning, indicating these are critical values that users should be aware of.

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: The document does not specify the sample size (e.g., number of gloves) used for testing each chemotherapy drug.
• Data Provenance: Not specified in the provided text, but testing based on ASTM standards is typically conducted in a laboratory setting. This would be prospective testing of new glove samples.

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 a physical product (surgical glove) test, not an AI/ML diagnostic or image-based assessment requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement of drug permeation.

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

• Not Applicable. This is a laboratory test, not an expert-based adjudication process.

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. No AI component or human reader study is mentioned.

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

• Not Applicable. No algorithm or AI component is involved.

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

• The "ground truth" in this context is established by physical laboratory measurements of chemotherapy drug permeation through the glove material, following the methodology described in ASTM D6978-05.

8. The sample size for the training set

• Not Applicable. No AI/ML model or training set is mentioned.

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

• Not Applicable. No AI/ML model or training set is mentioned.

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A Non-Sterile Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves Powder Free Grey Color Non-Sterile

The provided document is a 510(k) clearance letter from the FDA for Nugard Nitrile Examination Gloves. It does not contain information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets specific performance criteria as typically expected for software or AI-powered devices.

Instead, this document indicates that the device (examination gloves) has been found substantially equivalent to legally marketed predicate devices. The "Indications for Use" section (Page 3) briefly describes the purpose of the gloves.

Therefore, I cannot extract the requested information about acceptance criteria and a study from this document, as it is not relevant to the type of information typically found in a 510(k) clearance for examination gloves. The questions you posed (sample size for test/training set, expert qualifications, adjudication method, MRMC study, etc.) are generally applicable to the evaluation of diagnostic algorithms or imaging devices, not to a basic medical device like gloves.

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The surgeon's gloves are sterile gloves to be worn by surqeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.

Latex Surgical Gloves Powdered, Sterile.

The provided document is an FDA 510(k) clearance letter for "Latex Surgical Gloves Powdered, Sterile." It determines substantial equivalence for a medical device but does not contain information about acceptance criteria, efficacy studies, or device performance metrics typically associated with AI/ML-driven diagnostics or complex medical devices.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. The document is primarily regulatory correspondence.

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This Surgeon's glove is a device made of natural rubber intended to be worn by This Surgeon's glove to a so notect a surgical wound from contamination.

Sensiflex Plus, Polymer Coated Latex Surgical Glove Powder Free, Sterile, Coated with Aloe Vera, contains 50 micrograms or less of total water extractable protein per gram.

This document is a 510(k) premarket notification decision letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software devices. The acceptance criteria for this type of device (surgical glove) are generally related to manufacturing standards, material properties, and sterility, which would be covered by general controls and specific standards for gloves.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the product.

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