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The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.

The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise four layers of material: an outer layer of spun bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption).

Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

This document is a 510(k) premarket notification for the Innonix Anti-Influenza Child's Face Mask, detailing its acceptance criteria and non-clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

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