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Laglove TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

Laglove ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Pink Color)

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria and study details for a medical device's performance. The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and safety/effectiveness profiles.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided text.

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Laglove TM Brand Nitrile Examination Gloves, Powdered, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

Laglove TM Brand Nitrile Examination Gloves, Powdered, Non-Sterile. (Pink Color)

The provided text is a 510(k) premarket notification letter from the FDA for Laglove™ Brand Nitrile Examination Gloves, Powdered, Non-Sterile (Pink). This document is a regulatory approval for a medical device and thus does not contain information about an AI/ML study, device performance, acceptance criteria, or ground truth establishment.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device meets acceptance criteria based on this document. This document pertains to the regulatory clearance of examination gloves, which are physical medical devices, not AI/ML systems.

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Laglove TM Brand Latex Examination Gloves, Powdered, Non - Sterile (Pink, Green, Violet) is a patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Laglove ™ Brand Latex Examination Gloves, Powdered, Non-Sterile. (Pink, Green, Violet)

This document is a 510(k) clearance letter from the FDA for medical examination gloves and does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter confirms that the Laglove™ Brand Latex Examination Gloves, Powdered, Non-Sterile are substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other general responsibilities under the Federal Food, Drug, and Cosmetic Act.

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

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LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) is a disposable patient examination glove which is worn on the hand of a healthcare and similar personnel to prevent contamination between patient and examiner.

LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)

The provided text is a 510(k) Premarket Notification from the FDA for medical gloves. It does not contain any information about a study that proves a device meets acceptance criteria in the way you've described for AI/medical imaging devices.

The document is a regulatory approval for "LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free-Blue Color)", establishing its substantial equivalence to legally marketed predicate devices. This type of regulatory submission for Class I medical devices like examination gloves primarily focuses on:

• Manufacturing standards: Ensuring the gloves are produced under good manufacturing practices.
• Material safety: Demonstrating the materials used are safe for patient contact.
• Performance specifications: Meeting established physical properties for gloves (e.g., tensile strength, puncture resistance, freedom from holes).

The details you've requested (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typical for the evaluation of diagnostic devices, especially those utilizing AI or complex algorithms for image analysis or disease detection.

Therefore, I cannot provide the requested information based on the provided text because it is not relevant to the type of device and regulatory submission discussed.

To reiterate, this document is a letter from the FDA granting clearance for a physical medical device (examination gloves), not a report on a clinical or performance study involving complex data analysis or AI.

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LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber intended to be worn by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.

LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber.

This document is a 510(k) premarket notification approval letter for the "Laglove™ Brand Nitrile Surgical Glove-Trade Name: Sterile (Powdered)". As such, it does not contain information about acceptance criteria and a study proving a device meets those criteria.

The core purpose of this document is the FDA's declaration of "substantial equivalence" of the device to previously marketed devices, allowing it to be marketed.

Therefore, I cannot provide the requested information from the given text.

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LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worn by operating personnel during surgical procedures to help prevent contamination between health-care personnel and the patient.

disposable glove made of synthetic rubber

This document is a marketing clearance letter from the FDA for Laglove™ Brand Nitrile Surgical Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot answer the question based on the provided text.

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Laglove™ Brand, Colored Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Laglove™ Brand Colored Nitrile (Blue) Examination Gloves (Powdered)

This document is a 510(k) clearance letter from the FDA for a medical device: "Laglove™ Brand Blue Colored Nitrile Examination Glove Powdered". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The FDA's 510(k) process is about demonstrating substantial equivalence to a previously legally marketed device, not necessarily proving that a device meets specific performance acceptance criteria via a detailed study as described in the prompt. While manufacturers submit data to support substantial equivalence, the content provided here is the outcome of that review, not the detailed study results.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is concerned with regulatory approval based on equivalence, not a performance study against specific acceptance criteria.

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