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

    TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER

    K Number: K011044 · Decision Sep 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    40
    Review Days
    158

    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
    TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
    K Number
    K011044
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shen Wei (Usa), Inc.
    Date Received
    April 5, 2001
    Decision Date
    September 10, 2001
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

    Similar 510(k) Clearances

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

    Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Latex Examination Glove Powder Free (Ocean Blue and Natural White)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder-Free Latex examination gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Non Sterile Powder Free Latex Examination Glove

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

    Other Clearances by Shen Wei (Usa), Inc.

    K Number Device Name
    K161074 Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
    K121811 POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
    K121528 POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
    K120890 POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
    K113233 POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
    K101436 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
    K100211 PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
    K092411 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
    K090194 POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
    K061756 TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
    Search all 40 clearances from Shen Wei (Usa), Inc. →