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

    OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM

    K Number: K984066 · Decision Jan 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    12
    Review Days
    58

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    Basic Information

    Device Name
    OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
    K Number
    K984066
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Omni Intl., Inc.
    Date Received
    November 16, 1998
    Decision Date
    January 13, 1999
    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 Omni Intl., Inc.

    K Number Device Name
    K984064 OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
    K853255 OMNIMED I.V. SOLUTION ADMIN. SET
    K851938 OMNIMED SURGICAL GOWN
    K851654 OMNIMED CLAMP
    K851734 OMNIMED SUPERIOR TRANSDUCER PROTECTOR
    K850706 F-SERIES IMPLANT
    K850112 OMNIMED IV SOLUTION ADMINISTRATION SET
    K850066 OMNIMED NASAL OXYGEN CANNULA
    K831147 OMNIPROBE ELECTRICAL NERVE STIMULATOR
    K821523 OMNI TENS
    Search all 12 clearances from Omni Intl., Inc. →