FDA Advisory No. 2020-1181 || List of FDA Notified Medical Face Masks

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

  PRODUCT NAME COMPANY NAME
1 Blue Cross Disposable Surgical Mask Pharmatechnica Laboratory Inc.
2 Disposable Face Mask Hexagon Medical Supplies
3 Face Mask PM2.5 Disposable Mask Funtastic International, Inc.
4 Indoplas Face Masks Indoplas Philippines, Inc.
5 Indoplas KN95 Face Mask Indoplas Philippines Inc.
6 Indoplas Face Mask Indoplas Philippines Inc.
7 KN95 Disposable Face Mask Funtastic International, Inc.
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, Inc.
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 Inc.
15 Sure-Guard Carbon Face Mask AMB HK Enterprises Inc.
16 Sure-Guard Face Mask AMB HK Enterprises Inc.
17 Sure-Guard® Device Name: KN95 Protective Mask AMB HK Enterprises Inc.

The above list shall be regularly updated. For reference, please click the link: https://docs.google.com/spreadsheets/d/1OAE1MAByyve9wcqKiwlVifGtMUCoaHe7ntgSwV9JMvw/edit#gid=0

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

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, KN95 or similar face masks) that failed the performance requirement of greater than or equal to 95 percent (%) 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.fda.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 [email protected] or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1181

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