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

    LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED

    K Number: K982901 · Decision Dec 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    126

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    Basic Information

    Device Name
    LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
    K Number
    K982901
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vitalcare Group, Inc.
    Date Received
    August 17, 1998
    Decision Date
    December 21, 1998
    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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    K031748 VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
    K992289 VINYL POWDERED EXAM GLOVE / CAT.# 15-020
    K983016 GAUZE, SPONGES, CAT # 11-003
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