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    K Number
    K050193
    Device Name
    GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
    Manufacturer
    LOUIS M. GERSON CO., INC.
    Date Cleared
    2005-04-11

    (74 days)

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

    GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR

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

    The Gerson Model 2130 /2131 Disposable Surgical N95 Particulate Respirators are intended to be worn by operating room personnel during surgical procedures to protect the wearer from transfer of both the surgical patient and particulate material. The respirator is a single-use disposable.

    The 2130 and 2131 Model respirators are available in either blue or white colors.

    This device also meets CDC Guidelines for TB Exposure Control.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Gerson Model 2130/2131 Surgical N95 Particulate Respirators. It does not contain information about acceptance criteria or a study proving device performance in the context of the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample size, ground truth details, MRMC study, standalone performance, training set details) from the provided text.

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