LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060030
    Device Name
    THE DOUBLE GLOVE
    Manufacturer
    BIOBARRIER, INC.
    Date Cleared
    2006-06-27

    (174 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOBARRIER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powder-free, polymer coated, sterile surgeon's glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    The Double™ Glove, a Single-Donning™ Double Glove with 2 Discrete Layers Fused at the Wrist. A Class I, Powder-free, Polymer Coated, Latex Surgeon's Glove
    Ask a Question

    Page 1 of 1