BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MASC Surgical Mask

    K Number: K211984 · Decision Jul 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    1
    Review Days
    30

    Basic Information

    Device Name
    MASC Surgical Mask
    K Number
    K211984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mid-America Safety Corp.
    Date Received
    June 25, 2021
    Decision Date
    July 25, 2021
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FXX Mask, Surgical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FXX), ordered by most recent decision date.

    Procedure mask/Surgical mask/Face mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Aurelia Surgical Mask ASTM Level-3 (2130)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Surgical Face Mask (Tie on/ Ear loops)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRIMED Surgical Masks and PRIMED Procedure Masks

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Medical surgical mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all