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510(k) Data Aggregation

    K Number
    K971076
    Device Name
    PRIMED SHOE COVERS, PRIMED HEAD COVERS
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-13

    (295 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    PrimeLine Medical Products Inc., priMED brand Head and Shoe Covers
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    K Number
    K971191
    Device Name
    FAR-EAST SHOE COVERS
    Manufacturer
    FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
    Date Cleared
    1997-07-10

    (101 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
    Device Description
    Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
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    K Number
    K970815
    Device Name
    CONVERTORS IMPERVIOUS SHOE COVERS
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    1997-03-27

    (21 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Convertors® Impervious Shoe Covers are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material
    Device Description
    These shoe covers will be composed of a nonwoven fabric hot melt adhesively laminated to a synthetic polymer film. The nonwoven is a 1.5 osy blue spunbonded polypropylene. The film is a 1.25 mil embossed, polyethylene.
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    K Number
    K961342
    Device Name
    SHOE COVER, NON-STERILE
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1996-12-30

    (285 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955835
    Device Name
    FLUID BARRIER BOOT KNEE & ANKLE-HIGH
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1996-11-19

    (329 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
    Device Description
    The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.
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