BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BOUNDARY SINGLE-USE GOWNS

    K Number: K834332 · Decision May 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    72
    Review Days
    141

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    Basic Information

    Device Name
    BOUNDARY SINGLE-USE GOWNS
    K Number
    K834332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Procter & Gamble Mfg. Co.
    Date Received
    December 12, 1983
    Decision Date
    May 1, 1984
    Product Code
    FYA
    Advisory Committee
    General, Plastic Surgery
    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
    FYA Gown, Surgical

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    Other Clearances by Procter & Gamble Mfg. Co.

    K Number Device Name
    K873457 SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
    K873036 ATTENDS INCONTINENT BRIEF
    K864673 UNSCENTED MENSTRUAL PAD
    K861863 MODIFIED PROTECTIVE GARMENT
    K862348 SINGLE-USE PATIENT UNDERPAD
    K860598 MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
    K853880 ATTENDS DISPOS. UNDERPAD
    K853000 SCENTED ALWAYS PANTILINERS
    K852985 UNSCENTED ALWAYS PANTILINERS
    K850956 ALWAYS MAXIPADS - SCENTED
    Search all 72 clearances from Procter & Gamble Mfg. Co. →