K151208 - 510(k) Premarket Notification

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    Device Classification Name Polymer Patient Examination Glove
    510(k) Number K151208
    Device Name Powder Free Nitrile Examination Glove
    Applicant
    Vrg Khai Hoan Joint Stock Company
    Cau Sat Hamlet, Lai Hung Commune
    Ben Cat District,, VN
    Applicant Contact PHAM NGOC THANH
    Correspondent
    Vrg Khai Hoan Joint Stock Company
    Cau Sat Hamlet, Lai Hung Commune
    Ben Cat District,, VN
    Correspondent Contact TERENCE LIM
    Regulation Number880.6250
    Classification Product Code
    LZA
    Date Received05/06/2015
    Decision Date 09/14/2015
    Decision Substantially Equivalent (SESE)
    Regulation Medical Specialty General Hospital
    510k Review Panel General Hospital
    Statement Statement
    Type Traditional
    Reviewed by Third Party No
    Combination Product No
    Predetermined ChangeControl Plan Authorized No
    Recalls CDRH Recalls
    - -

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