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

    LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)

    K Number: K946257 · Decision Jun 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    36
    Review Days
    167

    Basic Information

    Device Name
    LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
    K Number
    K946257
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SIAM SEMPERMED CORP. LTD.
    Date Received
    December 23, 1994
    Decision Date
    June 8, 1995
    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 SIAM SEMPERMED CORP. LTD.

    K Number Device Name
    K121549 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
    K122363 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K100907 NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
    K082957 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
    K083755 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
    K081911 NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
    K081910 NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
    K081907 NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
    K080520 NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
    K070639 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
    Search all 36 clearances from SIAM SEMPERMED CORP. LTD. →