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

    PROTECT-AIDS UNDERGLOVE

    K Number: K880439 · Decision Oct 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    252

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    Basic Information

    Device Name
    PROTECT-AIDS UNDERGLOVE
    K Number
    K880439
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Armor Corp.
    Date Received
    February 2, 1988
    Decision Date
    October 11, 1988
    Product Code
    LYU
    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
    LYU Accessory, Surgical Apparel

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    Other Clearances by Medical Armor Corp.

    K Number Device Name
    K923229 MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE
    K912737 MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV
    K912457 MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO
    K880440 PROTECT-AIDS AUTOPSY UNDERGLOVE