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

    SAFESKIN POWDERED EXAMINATION GLOVE

    K Number: K970899 · Decision May 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    24
    Review Days
    56

    Basic Information

    Device Name
    SAFESKIN POWDERED EXAMINATION GLOVE
    K Number
    K970899
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SAFESKIN CORP.
    Date Received
    March 11, 1997
    Decision Date
    May 6, 1997
    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 SAFESKIN CORP.

    K Number Device Name
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    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
    K962139 SAFESKIN
    K952993 SAFESKIN SUPRA
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