BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STERILE SURGICAL GLOVES

    K Number: K891308 · Decision Apr 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    7
    Review Days
    48

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    Basic Information

    Device Name
    STERILE SURGICAL GLOVES
    K Number
    K891308
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Carl Parker Associates, Inc.
    Date Received
    March 9, 1989
    Decision Date
    April 26, 1989
    Product Code
    KGO
    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
    KGO Surgeon'S Gloves

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    Other Clearances by Carl Parker Associates, Inc.

    K Number Device Name
    K971130 DEFEND FLUID RESISTANT PLEATED MASK
    K962654 COMPLEAT SURGICAL MASK
    K932056 DEFEND SELF-SEALING STERILIZATION POUCH
    K891257 DEFEND LATEX EXAMINATION GLOVES
    K891157 DEFEND LATEX EXAMINATION GLOVES
    K871558 DENTAL FACE MASKS, POLYESTER