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

    EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV

    K Number: K120045 · Decision Jun 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    7
    Review Days
    158

    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
    EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
    K Number
    K120045
    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
    Exact Medical Manufacturing, Inc.
    Date Received
    January 6, 2012
    Decision Date
    June 12, 2012
    Product Code
    FYA
    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
    FYA Gown, Surgical

    Similar 510(k) Clearances

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

    Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

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

    BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

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

    Cardinal Health™ Poly Reinforced Surgical Gown

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

    Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

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

    Copioumed AAMI 3 Surgical Gown

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

    Henan Yadu Level 4 Surgical Gowns (Reinforced)

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

    Other Clearances by Exact Medical Manufacturing, Inc.

    K Number Device Name
    K121919 SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
    K111535 EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
    K101598 EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
    K101688 EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
    K101689 EMM EQUIPMENT COVER-POLYTHYLENE
    K101593 EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL