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The Food and Drug Administration (FDA) informs all healthcare professional and the general public that the product Klean by Luxeorganix Face Masks 3Ply Earloop Disposable, has been verified to be a non-medical device product and is, therefore, not under the FDA jurisdiction.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-2053 is hereby lifted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at cdrrhr@fda.gov.ph, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

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