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RespoKare

INNONIX TECHNOLOGIES LIMITED · Model RK-200-2005A-610C · UDI-DI 00840039200640

510(k) clearances

Adverse events

Recalls

Facilities

Description

The RespoKare Anti-viral Child Mask 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 pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The RespoKare Anti-viral Child Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6% and zinc 1.6%) that inactivate influenza viruses.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.