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

    VINYL POWDERED EXAM GLOVE / CAT.# 15-020

    K Number: K992289 · Decision Aug 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    VINYL POWDERED EXAM GLOVE / CAT.# 15-020
    K Number
    K992289
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vitalcare Group, Inc.
    Date Received
    July 7, 1999
    Decision Date
    August 4, 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 Vitalcare Group, Inc.

    K Number Device Name
    K060109 OMI RETRACTABLE SAFETY SYRINGE
    K050906 VITALCARE I.V. ADMINISTRATION SET
    K040916 VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
    K031748 VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
    K983016 GAUZE, SPONGES, CAT # 11-003
    K983716 VITALCARE DISPOSABLE VAGINAL SPECULUM
    K982901 LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED