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

    Powder Free Nitrile Examination Gloves (Orange)

    K Number: K171541 · Decision Sep 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    15
    Review Days
    117

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    Basic Information

    Device Name
    Powder Free Nitrile Examination Gloves (Orange)
    K Number
    K171541
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Received
    May 26, 2017
    Decision Date
    September 20, 2017
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Comfort Rubber Gloves Industries Sdn. Bhd.

    K Number Device Name
    K250069 Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
    K240269 Nitrile Powder Free Examination Gloves Biodegradable (Green)
    K241528 Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
    K192954 Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
    K200181 Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K190080 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
    K180476 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    K162405 Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)
    K110297 POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
    K101917 COMFORT RUBBER GLOVES IND.SDN.BHD.
    Search all 15 clearances from Comfort Rubber Gloves Industries Sdn. Bhd. →