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    FDA Advisory No.2020-1181

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    Are Pee Etc
    FDA

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    FDA Advisory No.2020-1181

    Uploaded by

    Are Pee Etc
    107 views2 pages
    FDA

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    FDA Advisory No.2020-1181 (1)

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    FDA

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Download as pdf
    107 views2 pages

    FDA Advisory No.2020-1181

    Uploaded by

    Are Pee Etc
    FDA

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Download as pdf
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    Republic of the Philippines Department of Health Ma FOOD AND DRUG ADMINISTRATION —®™**™!- Sinners ig JUN 2000 TO: ALL HEALTHCARE PROFESSIONALS AND THE GENERAL PUBLIC SUBJECT: List of FDA Notified Medical Face Masks xo, SEDGE 81 In the interest of protecting public health and safety, the Food and Drug Administration (FDA) hereby provides the list of registered face masks f medical use as of 16 June 2020: PRODUCT NAME. COMPANY NAME Blue Cross Disposable Surgical Mask Pharmatechnica Laboratory Ine. Disposable Face Mask [Hexagon Medical Supplies Face Mask PM2.5 Disposable Mask [Funtastic Intemational, Inc. indoplas Face Masks Indoplas Philippines, Inc. Indoplas Philippines Inc. [indoplas Face Mask Indoplas Philippines Ine. KIN9S Disposable Face Mask Funtastic Intemational, Inc. 1 2: 3 4 5_|Indoplas KN95 Face Mask 6 7 8 McBride Device Name: KN95 Protective Mask |AMB HK Enterprises Inc. 9 [McBride Face Mask AMB HK Enterprises Inc. 10 [Mediclean Device Name: Face Mask AMB HK Enterprises Inc. 11 |Resprotec Disposable Surgical Mask Pharmatechnica Laboratory, Ine. 12 |Safeplus Face Mask |AMB HK Enterprises Inc. 13 |Safeplus Face Mask For Kids [AMB HK Enterprises Inc. 14 |Safeplus KN95 Protective Mask [AMB HK Enterprises Ine. 15 |Sure-Guard Carbon Face Mask AMB HK Enterprises Ine. 16 |Sure-Guard Face Mask AMB HK Enterprises Inc. Mask 17 |Sure-Guard? Device Name: KN95 Protective AMB HK Enterprises Ine. The above list shall be regularly updated. hitps://does.google.com/spreadsheets/d/1OAE1 MAB: 9iMvw/editigid=0 For reference, please click the link ve9weqKiwlVifGtMUCoaHeTntgSwV Retailers, hospitals and other healthcare facilities are hereby advised to procure only FDA notified medical face masks from FDA licensed manufacturers and distributors, Civie Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines ‘Trunk Line +63 2 857 1900 Website: www.fila.gov.ph. Fax +63 2 807 0751 Email: info@fida.gov.ph The public is enjoined to be vigilant in the purchase and use of face masks in light of the proliferation of these products in the market to curb the spread of COVID-19. The public is likewise advised to purchase health products only from legitimate and reputable retailers or establishments, In addition, the FDA informs all concerned of the list of respirators (N95, KN9S or similar face masks) that failed the performance requirement of greater than or equal to 95 percent (6) filtration efficiency assessed by the United States (US) Centers for Disease Control and Prevention (CDC) - The National Institute for Occupational Safety and Health (NIOSH). These products were recalled and are currently not authorized by the US-FDA. The public is advised not to use these respirators especially healthcare workers who provide care to COVID-19 patients in settings and areas where aerosol generating procedures are undertaken. The list can be accessed at https://www. fla. gov/media/137928/download, For more information and inquiries, kindly contact the FDA ~ Center for Device Regulation, Radiation Health, and Research through e-mail at edrrhr@fda.gov.ph or call (02) 857-1900 loc. 8301 Dissemination of this advisory to all concemed is hereby requested 4u ROL. genau D. DOMINGO, MD ire -ctor General DTN 2020061141923

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