BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Medical Face Mask (M001)

    K Number: K221273 · Decision Jun 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    4
    Review Days
    57

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Medical Face Mask (M001)
    K Number
    K221273
    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
    Xingyu Medical Tech Co., Ltd.
    Date Received
    May 2, 2022
    Decision Date
    June 28, 2022
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    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.

    HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

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

    Surgical Face Mask (Ear mount)

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

    Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

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

    Disposable Surgical Face Mask (3P00B, C2900)

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

    Disposable Medical Face Mask

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

    KP Protective Face Mask

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

    Other Clearances by Xingyu Medical Tech Co., Ltd.

    K Number Device Name
    K240629 Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
    K212735 Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
    K212578 Nitrile disposable examination gloves