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Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non Sterile Powder Free Latex Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Latex Examination Gloves." It certifies that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI/software performance as requested in your prompt.

The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices (e.g., for diagnostic imaging), where performance metrics like sensitivity, specificity, or AUC are critical, and detailed study methodologies are required to demonstrate clinical validity.

This document pertains to a Class I medical device (non-powdered patient examination glove) which is a physical product, not a software or AI-based device. Therefore, the type of information you are seeking (AI performance, MRMC studies, ground truth establishment for algorithms, etc.) is not applicable and not present in this document.

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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.

Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device that would involve AI, human readers, or specific performance metrics like sensitivity or specificity.

The document is a 510(k) clearance letter from the FDA for Non-sterile, Powder-Free Latex Examination Gloves. This type of device does not typically involve complex performance studies with AI, human interpretation, or ground truth establishment in the way described in your request. The clearance is based on substantial equivalence to legally marketed predicate devices, and the "Indications for Use" section simply describes the intended use of the gloves for preventing contamination.

Therefore, I cannot provide the requested information as it is not present in the given text.

Ask a specific question about this device

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove contains 50 micrograms or less of total water extractable protein per gram.

CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions

Non-sterile, Powder-Free Latex Examination Glove

This document is a 510(k) premarket notification decision letter from the FDA for a Non-sterile, Powder-Free Latex Examination Glove. It is not for a medical device that utilizes AI or algorithmic performance, therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, and expert involvement is not applicable to this document.

The document discusses substantial equivalence to predicate devices for a physical product (gloves) and outlines regulatory requirements for such products, not performance metrics for an AI/algorithm-based device.

Ask a specific question about this device