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

    NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE

    K Number: K932404 · Decision May 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    24
    Review Days
    370

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    Basic Information

    Device Name
    NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
    K Number
    K932404
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Safeskin Corp.
    Date Received
    May 13, 1993
    Decision Date
    May 18, 1994
    Product Code
    FMC
    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
    FMC Patient Examination Glove

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    Other Clearances by Safeskin Corp.

    K Number Device Name
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    K994081 SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
    K992830 SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
    K992210 SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
    K992162 SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
    K992062 SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
    K991951 SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
    K991317 POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
    K970899 SAFESKIN POWDERED EXAMINATION GLOVE
    K962139 SAFESKIN
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