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A colored, powder free and polymer opated patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be wom on the hands or finger(s) for medical purposes to provide a bantier against potentially mlectious materials and other contaminants. The colors, pink, blue, green and violet are added respectively to the latex in the production process for the intended colored glove.

Colored Powder Free And Polymer Ceated Patient Examination Glove (Pink, Blue, Green and Violet) With A Protein Claim Of Less Than 50 pargm Glove.

This FDA clearance letter for the Glovco (M) SDN BHD Colored Powder Free and Polymer Coated Patient Examination Glove (K051345) does not contain the detailed information necessary to answer your questions about acceptance criteria and the specifics of a study proving device performance.

FDA 510(k) clearance letters primarily focus on determining substantial equivalence to a legally marketed predicate device, as opposed to providing in-depth performance study results. The letter confirms that the device is substantially equivalent for its intended use, but it doesn't typically include data tables, sample sizes, expert qualifications, or details about the method by which studies are conducted.

To answer your questions, one would need to review the actual 510(k) submission document (or similar regulatory submission) prepared by Glovco (M) SDN BHD, which would contain the performance summary and supporting data. This letter only provides a summary of the FDA's decision.

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A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile 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 ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.

A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile 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 ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.

This document is a 510(k) clearance letter for Powder-Free, Black, Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The letter confirms substantial equivalence to a predicate device, which is based on shared characteristics and performance attributes rather than a specific study outlined here.

Therefore, I cannot provide the requested information.

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A patient examination glove that is worn by the healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Black Coloured Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 micrograms or less)

This document is a 510(k) premarket notification for latex examination gloves. It does not contain information about a study proving a device meets acceptance criteria in the context of an AI/ML medical device. The document is concerned with the regulatory clearance of a medical glove. Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this input.

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A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient

Powder-Free Nitrile Examination Glove, (Purple)

The provided text is an FDA 510(k) clearance letter for Powder-Free Nitrile Examination Gloves. It primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory obligations.

Therefore, the document does not contain any information regarding:

• Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc.)
• Details of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Multi Reader Multi Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used.
• Sample size or ground truth establishment for a training set.

The 510(k) process for devices like examination gloves typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through conformance to recognized standards (e.g., ASTM standards for glove integrity) and bench testing, rather than complex clinical studies with AI components, ground truth, or expert review panels.

In summary, none of the requested information about acceptance criteria or specific study details for proving performance is available in the provided text. The document focuses on regulatory clearance based on substantial equivalence.

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A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient

Powder-Free Nitrile Examination Glove, BLUE

This FDA 510(k) clearance letter and associated documents describe the approval of "Powder-Free Nitrile Examination Glove, Blue." This is a medical device approval, not an AI/ML device approval, and therefore the requested information regarding AI/ML device performance, study design, and ground truth establishment is not applicable.

The document indicates that the device is a "patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient."

Key points from the document regarding the device's regulatory pathway:

• Regulation Number: 880.6250
• Regulation Name: Patient Examination Gloves
• Regulatory Class: I (indicating lower risk, typically cleared via 510(k) processes without extensive clinical trials)
• Product Code: LZA
• Substantial Equivalence: The device was found substantially equivalent to legally marketed predicate devices, which is the primary basis for 510(k) clearance. This means it performs similarly to other gloves already on the market and has the same intended use.

Since this is a Class I device and the clearance is based on substantial equivalence to existing devices, the types of detailed performance studies and ground truth establishment typically required for AI/ML devices or higher-risk medical devices are not present or required in this submission. The acceptance criteria for such a device would generally relate to manufacturing standards, biocompatibility, and physical properties (e.g., tensile strength, barrier integrity) that are assessed through laboratory testing rather than human reader studies or large-scale clinical trials.

Therefore, the requested information cannot be provided as it pertains to a different type of medical device and regulatory pathway.

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A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient.

Powdered Latex Examination Gloves with Protein and Powder Claim (100 MICROGRAMS OF LESS)

The provided text is a 510(k) pre-market notification letter from the FDA regarding "Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim (100 micrograms or less)". This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, or performance results of a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is strictly for regulatory approval of a medical device based on substantial equivalence.

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A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient

Powder-free Chlorinated Latex Examination Gloves with Protein Labeling Claim

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder-free Chlorinated Latex Examination Gloves With Protein Labeling Claim". This document is a regulatory approval for a medical device (examination gloves) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical study for a diagnostic or therapeutic device would.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety or effectiveness.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions typically pertain to studies involving the performance of a diagnostic or treatment device, often involving metrics like sensitivity, specificity, accuracy, and expert involvement for ground truth, which are not applicable to the 510(k) approval process for examination gloves as described here.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient

Powder-free Latex Examination Gloves with Protein Labeling Claim (50 micrograms OR LESS)

This document is a 510(k) premarket notification for Glovco Powder-Free Latex Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a letter from the FDA acknowledging the 510(k) submission and determining substantial equivalence, along with the device's indications for use.

Therefore, I cannot provide the requested information about acceptance criteria and a study from the supplied text.

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A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare and the patient.

Powdered Latex Examination Gloves with Protein Labeling Claim

The provided document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves Powdered, with Trade Name: Protein Labeling Claim (50 Micrograms or Less Per Gram)". This document is a regulatory approval and does not contain the acceptance criteria or a study proving the device meets the acceptance criteria for an AI/ML powered device.

The letter states that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, safety, and effectiveness. However, it does not detail specific performance metrics, sample sizes, expert ground truth, or study designs that would be relevant for evaluating an AI/ML diagnostic or screening device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria based on the input document. The input relates to the regulatory approval of a physical medical device (gloves), not an AI/ML software device.

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