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510(k) Data Aggregation

    K Number
    K971702
    Device Name
    FAR-EAST BARRIER GOWNS
    Manufacturer
    FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
    Date Cleared
    1997-07-08

    (61 days)

    Product Code
    FYC,DAT
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FAR-EAST BARRIER GOWNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Isolation for Far-East Barrier Gowns

    Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.

    Device Description

    Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "Far-East Isolation Gowns." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI-powered medical device.

    The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

    Substantial equivalence is based on comparing the new device to a predicate device, not on specific performance criteria demonstrated through a clinical study as would be expected for an AI device.

    Therefore, I cannot provide the requested information. The document pertains to general medical gowns, not an AI device, and the clearance is based on substantial equivalence, not a performance study.

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