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

    OPERATING ROOM TOWELS -STERILE & NON-STERILE

    K Number: K881396 · Decision Apr 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    11
    Review Days
    25

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    Basic Information

    Device Name
    OPERATING ROOM TOWELS -STERILE & NON-STERILE
    K Number
    K881396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    A Plus International, Inc.
    Date Received
    April 4, 1988
    Decision Date
    April 29, 1988
    Product Code
    KKX
    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
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by A Plus International, Inc.

    K Number Device Name
    K213001 Procedure Mask, Surgical Mask
    K102861 SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
    K093169 SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
    K031353 SOLUTION FACE MASKS
    K882283 BOUFFANT CAP
    K882281 GOWN, ISOLATION, SURGICAL (FYC)
    K882284 SURGEONS CAP
    K882282 SUIT, SURGICAL
    K882280 COVER, SHOE OPERATING ROOM
    K881395 GAUZE AND LAP SPONGES -STERILE & NON-STERILE
    Search all 11 clearances from A Plus International, Inc. →