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

    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

    K Number: K030094 · Decision Apr 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    795
    Applicant Total
    12
    Review Days
    81

    Basic Information

    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
    K Number
    K030094
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
    Date Received
    January 10, 2003
    Decision Date
    April 1, 2003
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.

    K Number Device Name
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    K030148 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
    K023560 ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
    K023343 ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
    K992100 PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED
    K991457 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
    K990299 POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
    K990267 POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
    K990081 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED
    Search all 12 clearances from SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. →