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510(k) Data Aggregation

    K Number
    K971917
    Device Name
    KENTRON'S ISOLATION GOWN
    Manufacturer
    KENTRON HEALTH CARE, INC.
    Date Cleared
    1997-09-19

    (119 days)

    Product Code
    FYC
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KENTRON'S ISOLATION GOWN

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

    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.

    Device Description

    ISOLATION GOWN

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Kentron's Isolation Gown (K971917). It states that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

    Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets criteria. It is a regulatory clearance letter, not a performance study report.

    Therefore, I cannot provide the requested table and study details based on the provided text. The document focuses on regulatory approval based on substantial equivalence, not on specific performance metrics or clinical study results for the device itself.

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