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

    MODIFICATION TO CONVERTORS SURGICAL GOWNS

    K Number: K001189 · Decision Apr 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    63
    Review Days
    9

    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
    MODIFICATION TO CONVERTORS SURGICAL GOWNS
    K Number
    K001189
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allegiance Healthcare Corp.
    Date Received
    April 12, 2000
    Decision Date
    April 21, 2000
    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 Allegiance Healthcare Corp.

    K Number Device Name
    K023673 AIRLIFE DEMAND NASAL CANNULA
    K023419 TRILAMINATE DRAPES/TIBURON
    K024120 MODIFICATION TO TEMNO BIOPSY NEEDLES
    K024292 MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
    K024102 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    K023425 DRAPES WITH ABSORBENT REINFORCEMENT
    K022765 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023170 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023167 BREATHABLE SURGICAL GOWN
    K012931 GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
    Search all 63 clearances from Allegiance Healthcare Corp. →