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These devices, both sterile and non sterile, are indicated for external use only and are intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids, and dress wounds.

Furlong Industries' Non-X-Ray Detectable Gauze Sponges/Bandages, both sterile and non sterile, consist of cotton, rayon or rayon/polyester formed material and/or cellulose. This device is for externation of conly for cleaning wounds, scrubbing, dressing and fluid absorption.

The provided text does not contain information on acceptance criteria or a study proving device performance. The document is a 510(k) submission for a medical device (non-absorbable gauze for external use) and primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, the "Clinical Tests" section on page 1 of the "SUMMARY OF SAFETY AND EFFECTIVENESS" states:

"5. CLINICAL TESTS: There are no clinical studies that have been performed on these devices, both for the predicate and the new devices."

This explicitly indicates that no clinical studies were performed to evaluate the performance of this device against acceptance criteria. Therefore, no information on sample sizes, ground truth, expert involvement, or any type of performance study (standalone or MRMC) is available in the provided text.

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