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510(k) Data Aggregation

    K Number
    K220442
    Device Name
    Synguard Nitrile Exam Glove
    Manufacturer
    Tianjin Aoshang Outdoor Equipment Co., Ltd.
    Date Cleared
    2022-05-12

    (85 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Aoshang Outdoor Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synguard Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
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    K Number
    K210030
    Device Name
    Medical Surgical Mask
    Manufacturer
    Tianjin Aoshang Outdoor Equipment Co., Ltd.
    Date Cleared
    2021-04-23

    (108 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Aoshang Outdoor Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
    Device Description
    The Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.
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