BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Surgical Face Mask (FM-34EE,FM-44EE)

    K Number: K220597 · Decision May 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    6
    Review Days
    86

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    Basic Information

    Device Name
    Disposable Surgical Face Mask (FM-34EE,FM-44EE)
    K Number
    K220597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qingdao Bestex Rubber & Plastic Products Co., Ltd.
    Date Received
    March 1, 2022
    Decision Date
    May 26, 2022
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    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
    FXX Mask, Surgical

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    Other Clearances by Qingdao Bestex Rubber & Plastic Products Co., Ltd.

    K Number Device Name
    K042645 POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING
    K031157 POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
    K022566 POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO
    K012709 POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN)
    K002087 BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)