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

    SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES

    K Number: K993240 · Decision Oct 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
    K Number
    K993240
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shinemound Enterprise, Inc.
    Date Received
    September 27, 1999
    Decision Date
    October 27, 1999
    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 Shinemound Enterprise, Inc.

    K Number Device Name
    K051913 POWDERED LATEX PATIENT EXAMINATION GLOVES
    K994248 SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
    K994258 SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
    K993231 SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
    K971360 SYNTEX
    K972104 LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
    K970625 POLY-MED