BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA

    K Number: K992337 · Decision Aug 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    35

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
    K Number
    K992337
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mexpo Intl., Inc.
    Date Received
    July 13, 1999
    Decision Date
    August 17, 1999
    Product Code
    FMC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMC Patient Examination Glove

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FMC), ordered by most recent decision date.

    LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NITRILE RUBBER EXAMINATION GLOVES (POWERED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SURGICAL INSTRUMENT KIT, DISPOSABLE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COMPASEP

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Mexpo Intl., Inc.

    K Number Device Name
    K990210 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP
    K984040 BLOSSOM POWDERED LATEX EXAMINATION GLOVES
    K974782 LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES