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

    GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.

    K Number: K915636 · Decision Jul 13, 1992
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    4
    Review Days
    209

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    Basic Information

    Device Name
    GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.
    K Number
    K915636
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Associated Ent., Inc.
    Date Received
    December 17, 1991
    Decision Date
    July 13, 1992
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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    K924837 DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET
    K891835 BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)
    K891836 BUD BRAND PATIENT EXAMINATION GLOVES (LATEX)