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 8 March 2021:
| PRODUCT NAME | COMPANY NAME | |
| 1 | FACE MASK PM2.5 DISPOSABLE MASK | FUNTASTIC INTERNATIONAL |
| 2 | DISPOSABLE FACE MASK | HEXAGON MEDICAL SUPPLIES |
| 3 | MCBRIDE DEVICE NAME: KN95 PROTECTIVE MASK | AMB HK ENTERPRISES INC. |
| 4 | INDOPLAS FACE MASK | INDOPLAS PHILIPPINES INC. |
| 5 | KN95 DISPOSABLE FACE MASK | FUNTASTIC INTERNATIONAL, INC. |
| 6 | SAFEPLUS KN95 PROTECTIVE MASK | AMB HK ENTERPRISES INC. |
| 7 | INDOPLAS FACE MASKS | INDOPLAS PHILIPPINES INC. |
| 8 | SURE-GUARD® DEVICE NAME: KN95 PROTECTIVE MASK | AMB HK ENTERPRISES INC. |
| 9 | SURE-GUARD FACE MASK | AMB HK ENTERPRISES INC. |
| 10 | MEDICLEAN DEVICE NAME: FACE MASK | AMB HK ENTERPRISES INC. |
| 11 | MCBRIDE FACE MASK | AMB HK ENTERPRISES INC. |
| 12 | SURGITECH DISPOSABLE SURGICAL GOWN | MEDASIA MEDICAL PRODUCTS CORPORATION |
| 13 | SAFEPLUS FACE MASK | AMB HK ENTERPRISES INC. |
| 14 | RESPROTEC DISPOSABLE SURGICAL MASK | PHARMATECHNICA LABORATORY INC. |
| 15 | SURE-GUARD CARBON FACE MASK | AMB HK ENTERPRISES INC. |
| 16 | RESPOKARE ANTI-VIRAL FACE MASK (CHILD) | IDS MEDICAL SYSTEMS PHILIPPINES, INC. |
| 17 | BLUE CROSS DISPOSABLE SURGICAL MASK | PHARMATECHNICA LABORATORY INC. |
| 18 | SAFEPLUS FACE MASK FOR KIDS | AMB HK ENTERPRISES INC. |
| 19 | INDOPLAS KN95 FACE MASK | INDOPLAS PHILIPPINES INC. |
| 20 | ENDURE KN95 MASK | ENDURE MEDICAL, INC. |
| 21 | MCBRIDE FACE MASK | AMB HK ENTERPRISES INC. |
| 22 | EMS N88 SURGICAL FACE MASK | EMS COMPONENTS ASSEMBLY, INC. |
| 23 | MEDTECS FACE MASK | MEDTEX CORPORATION |
| 24 | ELITE TOKYO JAPAN FACE MASK FOR KIDS | INDOPLAS PHILIPPINES INC. |
| 25 | MCBRIDE FACE MASK FOR KIDS | AMB HK ENTERPRISES INC. |
| 26 | YOU JI BEAR DISPOSABLE MEDICAL MASK (NON-STERILE) | PHILIPPINE BLUE CROSS BIOTECH CORPORATION |
| 27 | ELITE TOKYO JAPAN FACE MASK | INDOPLAS PHILIPPINES INC. |
| 28 | SURGICAL MASK (STERILE) | FIREFLY ELECTRIC AND LIGHTING CORPORATION |
| 29 | 3M AURA™ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK | 3M PHILIPPINES, INC. |
| 30 | 3M VFLEX™ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK | 3M PHILIPPINES, INC. |
| 31 | 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK | 3M PHILIPPINES, INC. |
| 32 | BENEHAL N95 PARTICULATE RESPIRATOR | AMB HK ENTERPRISES INC. |
| 33 | RESPOKARE N95 RESPIRATOR PLUS ANTI-VIRAL FACE MASK | IDS MEDICAL SYSTEMS PHILIPPINES, INC. |
| 34 | RESPOKARE ANTI-VIRAL FACE MASK (ADULT) | IDS MEDICAL SYSTEMS PHILIPPINES, INC. |
| 35 | EMS KN95 RESPIRATORY PROTECTIVE MASK (5 LAYERS) | EMS COMPONENTS ASSEMBLY, INC. |
| 36 | EMS KN95 RESPIRATORY PROTECTIVE MASK (6 LAYERS) | EMS COMPONENTS ASSEMBLY, INC. |
| 37 | RISTEA FACE MASK | SURGICOM TRADING CORPORATION |
| 38 | BENEHAL N95 PARTICULATE RESPIRATOR (CARBON) | AMB HK ENTERPRISES INC. |
| 39 | PROHEALTHCARE DISPOSABLE SURGICAL FACE MASK | VMED MEDICAL CO. |
| 40 | “MEDTECS” STANDARD TIE-BACK FACE MASK | MEDTEX CORPORATION |
| 41 | “MEDTECS” STANDARD EAR-LOOP FACE MASK | MEDTEX CORPORATION |
| 42 | DISPOSABLE FACE MASK | QUANTA PAPER CORPORATION |
| 43 | “MEDTECS” N88 PROTECTIVE FACE MASK | MEDTEX CORPORATION |
| 44 | PARTNERS SURGICAL FACE MASK | CHAMPION BIOTECH AND PHARMA CORP |
| 45 | DISPOSABLE MEDICAL MASK (NON-STERILE) | FIREFLY ELECTRIC AND LIGHTING CORPORATION |
| 46 | MEDICAL SURGICAL MASK | LUOXIN PHARMACEUTICALS (PH) CORP |
| 47 | DISPOSABLE MEDICAL MASK (NON-STERILE) | LUOXIN PHARMACEUTICALS (PH) CORP |
| 48 | BYD SINGE-USE MEDICAL MASK | BYD PHILIPPINES CORP. |
| 49 | RUNDATOPLIN MEDICAL SURGICAL MASK (NON-STERILE) | AMBICA INTERNATIONAL CORPORATION |
| 50 | DISPOSABLE FACE MASK MEDICAL GRADE 3-PLY FACE MASK | ORTHONE, INC. |
| 51 | BYD N95 PARTICULATE RESPIRATOR | BYD PHILIPPINES CORP. |
| 52 | SURGICAL FACE MASK | PHIL PHARMAWEALTH, INC. |
| 53 | DISPOSABLE FACE MASK | JKA SAFETY FIRST TRADING CORP. |
| 54 | DISPOSABLE MEDICAL MASK (STERILE) | LUOXIN PHARMACEUTICALS (PH) CORP |
| 55 | N95 PARTICULATE RESPIRATOR | SUNWEST CONSTRUCTION AND DEVELOPMENT CORPORATION |
| 56 | BYD KN95 PARTICULATE RESPIRATOR | BYD PHILIPPINES CORP. |
| 57 | MEDIPLAST N95 PARTICULATE RESPIRATOR | AMB HK ENTERPRISES INC. |
| 58 | TUDOR SURGICAL FACE MASK ( DISPOSABLE) | CHAMPION BIOTECH AND PHARMA CORP |
| 59 | 3M NEXCARE EARLOOP MASK | 3M PHILIPPINES, INC. |
| 60 | N95 PARTICULATE RESPIRATOR | SUNWEST CONSTRUCTION AND DEVELOPMENT CORPORATION |
| 61 | WINNER SURGICAL FACE MASK EARLOOP, 3-PLY, BLUE | PINNACLE SUPPLIES & SERVICES UNLIMITED INC. |
| 62 | DISPOSABLE FACE MASK | NIPPON BIOPHARMACEUTICAL INDUSTRIES INC. |
| 63 | DISPOSABLE MEDICAL NON-WOVEN FACEMASK | ALVEZ COMMERCIAL, INC. |
| 64 | DISPOSABLE MEDICAL PROTECTIVE FACE MASK | NAGALAND DEVELOPMENT CORPORATION |
| 65 | WINNER MEDICAL FACE MASK TIE-ON, 3-PLY, BLUE | PINNACLE SUPPLIES & SERVICES UNLIMITED INC. |
| 66 | ENDURE SURGICAL FACE MASK | ENDURE MEDICAL, INC. |
| 67 | LIFE TEK W.E. CARE FACE MASK SURGICAL DISPOSABLE 3-PLY WITH EARLOOPS | LIFE TEK TRADING |
| 68 | ALWAYS KF94 PROTECTIVE FACE MASK | MEDIC-PRO CORP. |
| 69 | WINNER N95 FACE MASK HEAD-LOOP TYPE, EXTERNAL NOSEPIECE | PINNACLE SUPPLIES & SERVICES UNLIMITED INC. |
| 70 | N95 PARTICULATE RESPIRATOR | SUNWEST CONSTRUCTION AND DEVELOPMENT CORPORATION |
| 71 | N95 PARTICULATE RESPIRATOR | SUNWEST CONSTRUCTION AND DEVELOPMENT CORPORATION |
| 72 | RYCORTECH PRIME 3 PLY MEDICAL GRADE FACEMASK | RYCORTECH CORPORATION |
| 73 | GERMINATOR X MEDICAL LEVEL FACE MASK | SJ CONSO INC. |
| 74 | SURGITECH DISPOSABLE FACEMASK | MEDASIA MEDICAL PRODUCTS CORPORATION |
| 75 | MEDIPLAST KN95 PROTECTIVE MASK | AMB HK ENTERPRISES INC. |
| 76 | CHOPARD DISPOSABLE MEDICAL MASK | NIPPON BIOPHARMACEUTICAL INDUSTRIES INC. |
| 77 | RESPOKARE ANTI-VIRAL FACE MASK (ADULT) | IDS MEDICAL SYSTEMS PHILIPPINES, INC. |
| 78 | COVERU DISPOSABLE CHILDREN’S MASK | MEDTEX CORPORATION |
| 79 | MEDICAL FACE MASK | PHARMALLY PHARMACEUTICAL CORPORATION |
| 80 | GERMINATOR X MEDICAL LEVEL FACE MASK | SJ CONSO INC. |
| 81 | RYCORTECH 4 PLY MEDICAL GRADE FACE MASK | RYCORTECH CORPORATION |
| 82 | PANAMED® KN95-H PROTECTIVE MASK | PANAMED PHILIPPINES, INC. |
| 83 | NANO RESPIRATOR (KN95) | L&T INTERNATIONAL GROUP PHILS., INC. |
| 84 | BTL RESPIRATOR C-FIT HEALTHCARE RESPIRATOR | BTL MEDICAL TECHNOLOGIES, INC. |
| 85 | MEDIPLAST FACE MASK FOR KIDS | AMB HK ENTERPRISES INC. |
| 86 | SUPREME SURGICAL FACE MASK (TYPE IIR) | CHAMPION BIOTECH AND PHARMA CORP. |
| 87 | QUALISAFE KN95 PROTECTIVE MASK | IPOLYMER SOLUTIONS CORPORATION |
| 88 | TRUCARE SURGICAL FACE MASK (TYPE IIR) | CHAMPION BIOTECH AND PHARMA CORP |
| 89 | SURGITECH DISPOSABLE FACEMASK | MEDASIA MEDICAL PRODUCTS CORPORATION |
| 90 | PANAMED® KN95-W PROTECTIVE MASK | PANAMED PHILIPPINES, INC. |
| 91 | WHITE SWAN_SURGICAL MASK | ATGLOBAL ELECTRONICS MFG. |
| 92 | PARTNERS DISPOSABLE MEDICAL FACE MASK ( TYPE I) | CHAMPION BIOTECH AND PHARMA CORP. |
| 93 | KAROFI ® DISPOSABLE FACE MASK | ZAFIRE DISTRIBUTORS 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.
Furthermore, FDA strongly reminds all concerned that the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any unnotified medical face mask are prohibited pursuant to the provisions of Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”.
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) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No.2020-1181-A