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The Following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. These surgical masks are single use, disposable devices provided non-sterile.

3-ply EcoGuard B with Earloop, Model Number: ECO01
3-ply EcoGuard B with Tie-on, Model Number: ECO02

The proposed surgical masks are available in two models with three-ply pleated earloop or tie-on (EcoGuard B) masks with ear loops and nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops or ties are held in place over the users' mouth and nose by two elastic ear loops or four ties welded to the surgical mask. Neither the elastic ear loops, nor ties are made with natural rubber latex. The nose piece in the layers of surgical mask is to allow the user to fit the surgical mask around their nose, which is made of malleable polyethylene wire. The surgical masks are sold nonsterile and are intended to be single use, disposable devices.

This document is a 510(k) Premarket Notification summary for a surgical mask (EcoGuard B). It assesses the substantial equivalence of the new device to a legally marketed predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and biocompatibility testing, not clinical studies involving human patients or complex AI algorithm evaluation.

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1. A table of acceptance criteria and the reported device performance

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