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510(k) Data Aggregation
(142 days)
This single use surgical mask EFX3PLBLKMSK300 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposal device, provided non-sterile.
The device is a flat pleated type of mask the outer layer being black and the inner layer being black, utilizing ear loops to secure the mask in place, and a nose bridge is also incorporated for a proper fit around the nose. The device number is EFX3PLBLKMSK300.
The device is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, and the middle layer is made of melt-blown polypropylene filter material. The model EFX3PLBLKMSK300 device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polypropylene and spandex. The nose bridge contained within the device is placed between the layers of the surgical mask to allow the user to form the surgical mask properly around their nose. The nose bridge is made up of galvanized wire coated with polyethylene.
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