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A powder-free patient 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.

Model 1: Natural Latex Powder Free Polymer Coated Examination Gloves, with Vanilla Scent
Model 2: Orange Latex Powder Free Polymer Coated Examination Gloves, with Citric Scent
Model 3: Pink Latex Powder Free Polymer Coated Examination Gloves

I am sorry, but the provided text is a 510(k) premarket notification for "ILLUSION Powder Free Latex Examination Gloves." This document does not contain information about acceptance criteria or a study that proves a device meets such criteria for an AI or medical imaging device. It is a regulatory approval document for disposable medical gloves.

Therefore, I cannot extract the specific details you requested regarding acceptance criteria and study information for an AI/imaging device from this text.

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A patient examination glove is a disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination, contagious issue by the world. In the dentistry field.

Patient Examination Glove Oleicon Powder free polymer coated berce Cot Bubblegum ssented NR latef

The provided text is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)". This document is a regulatory approval for a medical device and does not contain any information about a study proving the device meets acceptance criteria.

The FDA letter grants substantial equivalence based on the device's similarity to a legally marketed predicate device, not on specific performance studies detailed in this document. Therefore, I cannot provide the requested information.

The document indicates:

• Device Name: Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)
• Regulation Number/Name: 880.6250 / Patient Examination Glove
• Regulatory Class: I
• Product Code: LYY
• Indications for Use: A disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination and in the dentistry field.

To answer your specific questions, one would need access to the full 510(k) submission documentation, which would include the raw data and study reports if they were required and submitted. The letter itself only confirms the FDA's decision based on that submission.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.

Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)."

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is an approval letter for a medical device (patient examination gloves), confirming that the device is substantially equivalent to legally marketed predicate devices. The letter primarily details the regulatory classification, general controls, and compliance requirements for the manufacturer.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

Ask a specific question about this device

Ask a specific question about this device

A patient 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.

Patient Examination Glove, Latex, Powder Free

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Patient Examination Glove, Latex, Powder Free." This document explicitly states that the device is substantially equivalent to legally marketed predicate devices. Crucially, it does not contain the specific information required to complete the table and answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.

The letter is an approval for market entry based on substantial equivalence, not a detailed report of a clinical trial or performance study against specific acceptance criteria. The FDA's finding of substantial equivalence means they believe the device is as safe and effective as a legally marketed predicate device, without necessarily requiring a new, comprehensive performance study that would generate the kind of data requested.

Therefore, I cannot extract the requested information from the provided text. The document is about regulatory approval, not a performance study report.

Ask a specific question about this device