BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    NIL (PATIENT EXAMINATION GLOVES - LATEX)

    K Number: K891865 · Decision May 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    59

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    Basic Information

    Device Name
    NIL (PATIENT EXAMINATION GLOVES - LATEX)
    K Number
    K891865
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medicare Industries, Inc.
    Date Received
    March 27, 1989
    Decision Date
    May 25, 1989
    Product Code
    LYY
    Advisory Committee
    General Hospital
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Medicare Industries, Inc.

    K Number Device Name
    K894197 LATEX EXAMINATION GLOVES
    K791434 SPONGE COUNTER BAGS
    K781980 RESPIRATORY THERAPY GAS POUCH
    K781981 DECONTAMINATION ITEMS BAG
    K781925 POUCHES, GAS STERILIZATION
    K781924 POUCHES AND TUBING, MEDI-SEAL