BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)

    K Number: K100611 · Decision Jul 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    15
    Review Days
    135

    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
    RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
    K Number
    K100611
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Riverstone Resources Sdn Bhd
    Date Received
    March 3, 2010
    Decision Date
    July 16, 2010
    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 Riverstone Resources Sdn Bhd

    K Number Device Name
    K220672 Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
    K220401 Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
    K200326 Powder Free Nitrile Examination Glove (Aqua Green)
    K190725 Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
    K180452 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
    K152542 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
    K133193 RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
    K112924 RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
    K112928 RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
    K100603 RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
    Search all 15 clearances from Riverstone Resources Sdn Bhd →