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The Hygenix 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.

The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire. The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex. The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.

Here's an analysis of the Hygenix device based on the provided FDA 510(k) summary, specifically focusing on its acceptance criteria and the study that proves it meets those criteria.

Acceptance Criteria and Device Performance for Hygenix (K232797)

The Hygenix device is a 3-ply disposable mask, and its performance is evaluated against established standards for surgical masks. The study proving its compliance is a non-clinical performance and biocompatibility testing regime.

1. Table of Acceptance Criteria and Reported Device Performance

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