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A patient examination gloves 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.

Powder-free Multi-ply Latex Examination Gloves, Polymer Coated on the Outside and Nitrile Coated on the Inside (Blue Color). With Protein Labeling claim 50ug/g or less of total extractable protein content.

This document is a 510(k) clearance letter from the FDA for Powder-Free Multi-Ply Latex Examination Gloves. It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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Patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prepowdered Latex Examination Glove - Blue color

This document is a 510(k) clearance letter from the FDA for a patient latex examination glove. It does not contain information about the acceptance criteria or a study proving that a device meets the acceptance criteria. Therefore, I cannot fulfill your request based on the provided text.

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For examination purposes for personnel and similar personnel to prevent contamination between health care worker and the patient's body, fluids and waste.

Powder-Free Latex Examination Glove (Polymer-Coated)

This document is a 510(k) clearance letter from the FDA for medical gloves (Powder-Free Latex Examination Glove). It does not contain information about acceptance criteria or a study proving device performance as it is a regulatory clearance document based on substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot fulfill your request based on the provided text.

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A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree, Blue Nitrile Examination Glove

This document is an FDA 510(k) clearance letter for examination gloves. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML devices or diagnostic tools.

Therefore, I cannot provide the requested information based on the provided text. The letter primarily confirms that the gloves are "substantially equivalent" to predicate devices already on the market, implying they meet existing standards for such products (e.g., for barrier protection, freedom from holes, biocompatibility, etc.), which are established through general controls provisions. However, these specific criteria and their associated testing results are not detailed in this clearance letter.

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Patient Examination

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for nitrile examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.

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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.

Not Found

This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. Therefore, I cannot extract the requested details.

Ask a specific question about this device

Ask a specific question about this device