FDA Warns Public Against use of the Following Face Masks

The Food and Drug Administration (FDA) on Wednesday, August 5, 2020, has warned all healthcare professionals and the general public, through the FDA Advisory No. 2020-1396, not to purchase and use misbranded face masks which are labels, description and instructions are in foreign characters.

What is a Misbranded Product

“A device shall be deemed misbranded if any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use”.

– Section 19(c) of Republic Act (RA) No. 3720 or the Food, Drug, and Cosmetic Act, amended by RA No. 9711 or the the Food and Drug Administration (FDA) Act of 2009

Face Mask Brands not to Use and Buy

The following are the brands of face masks FDA warns not to use and buy.

• Fu Le Bang Disposable Mask

• Flag World Face Mask

• MAsk
  

To All Concerned Establishments

According to the FDA, pursuant to Section 10 of RA No. 9711, the following actions are prohibited involving any misbranded health product:

• manufacture
• importation
• exportation
• sale
• offering for sale
• distribution
• transfer
• non-consumer use
• promotion
• advertising
• sponsorship

Thus, all concerned establishments are warned not to distribute, advertise, or sell the said violative medical products. Otherwise, they are to face regulatory actions and sanctions.

FDA to Ensure that the said Products are not Sold

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are the ones requested to ensure that the above-mentioned products are not sold or made available in the market or areas of jurisdiction.

Those who are to report any sale or distribution of the said products may email the FDA at [email protected].

 

List of FDA Notified Medical Face Masks

In the interest of protecting public health and safety, the FDA hereby provides the list of registered face masks for medical use as of 16 June 2020:

PRODUCT NAME	COMPANY NAME
Blue Cross Disposable Surgical Mask	Pharmatechnica Laboratory Inc.
Disposable Face Mask	Hexagon Medical Supplies
Elite Tokyo Japan Face Mask for Kids	Indoplas Philippines Inc.
Elite Tokyo Japan Face Mask	Indoplas Philippines Inc.
EMS N88 Surgical Face Mask	EMS Components Assembly, Inc.
Endure KN95 Mask	Endure Medical, Inc.
Face Mask PM2.5 Disposable Mask	Funtastic International, Inc.
Indoplas Face Masks	Indoplas Philippines, Inc.
Indoplas KN95 Face Mask	Indoplas Philippines Inc.
Indoplas Face Mask	Indoplas Philippines Inc.
KN95 Disposable Face Mask	Funtastic International, Inc.
McBride Device Name: KN95 Protective Mask	AMB HK Enterprises Inc.
McBride Face Mask	AMB HK Enterprises Inc.
Mediclean Device Name: Face Mask	AMB HK Enterprises Inc.
MEDTECS Face Mask	MEDTEX Corporation
Respokare Anti-Viral Face Mask (Child)	IDS Medical Systems Philippines, Inc.
Resprotec Disposable Surgical Mask	Pharmatechnica Laboratory, Inc.
Safeplus Face Mask	AMB HK Enterprises Inc.
Safeplus Face Mask For Kids	AMB HK Enterprises Inc.
Safeplus KN95 Protective Mask	AMB HK Enterprises Inc.
Sure-Guard Carbon Face Mask	AMB HK Enterprises Inc.
Sure-Guard Face Mask	AMB HK Enterprises Inc.
Sure-Guard® Device Name: KN95 Protective Mask	AMB HK Enterprises Inc.
YOU JI Bear Disposable Medical Mask (Non-Sterile)	Philippine Blue Cross Biotech Corporation

Retailers, hospitals, and other healthcare facilities are hereby advised to procure only FDA notified medical face masks from FDA licensed manufacturers and distributors.

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SOURCE

Food and Drug Administration (FDA)

FDA Advisory No. 2020-1396
FDA Advisory No. 2020-1181