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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Powder Free Synthetic Vinyl Patient Examination Gloves, White

This document (K031170) is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria.

The acceptance criteria typically refer to performance metrics (e.g., sensitivity, specificity, accuracy) that a medical device must achieve in a clinical study to be considered safe and effective for its intended use. This document is a regulatory approval notice, indicating that the device is substantially equivalent to legally marketed predicate devices, not a study report.

Therefore, I cannot extract the requested information from the provided text.

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A medical gloves i ; worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

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This document is a 510(k) clearance letter from the FDA for "Brothers Vinyl, Powder-Free, Patient Examination Gloves." It does not contain any information about acceptance criteria or a study proving device performance, as is typical for most 510(k) clearances, especially for Class I devices like examination gloves.

The letter explicitly states: "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the device was cleared because it was shown to be as safe and effective as a legally marketed predicate device, not because a new study was conducted to establish specific performance criteria or benchmarks.

Therefore, I cannot extract the requested information from this document. It is a regulatory clearance, not a technical report detailing performance studies.

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A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for "Brothers Vinyl, Powdered, Patient Examination Gloves," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classification (Class I).
• Applicable general controls provisions of the Act (annual registration, listing, GMP, labeling, misbranding, adulteration).
• Contact information for various FDA offices.
• The "Indications For Use" statement for the medical gloves.

There is no mention of specific performance metrics, acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies. Therefore, I cannot extract the information you requested based on the input provided.

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