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

    Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

    K Number: K211832 · Decision Sep 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    2
    Review Days
    86

    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
    Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
    K Number
    K211832
    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
    Zhejiang Lanhine Medical Products, Ltd.
    Date Received
    June 14, 2021
    Decision Date
    September 8, 2021
    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 Zhejiang Lanhine Medical Products, Ltd.

    K Number Device Name
    K211827 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)