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510(k) Data Aggregation

    K Number
    K984066
    Device Name
    OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
    Manufacturer
    OMNI INTL., INC.
    Date Cleared
    1999-01-13

    (58 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A glove to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    OmniGrip Latex Surgeons Gloves, Powder Free WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to OmniGrace (Thailand) Ltd. regarding their OmniGrip Latex Surgeons Gloves. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter primarily:

    • Confirms the FDA's review of the 510(k) notification.
    • States that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines general regulatory provisions applicable to the device.
    • Provides contact information for further regulatory guidance.
    • Includes an "Indications For Use" statement for the gloves.

    Therefore, I cannot provide the requested information.

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