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510(k) Data Aggregation

    K Number
    K221717
    Device Name
    Disposable Surgical Gown UM-148
    Date Cleared
    2022-09-20

    (99 days)

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

    Unimax Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
    Device Description
    The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and a blue color.
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    K Number
    K220749
    Device Name
    Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
    Date Cleared
    2022-05-13

    (60 days)

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

    Unimax Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
    Device Description
    Surgical Face Mask is composed of Nylon and Spandex ear loops, Iron-plastic nose clip, Inner layer Spunbond polypropylene, Middle Melt-blown polypropylene and outer Spun-bond polypropylene. The meltblown polypropylene material acts as the filter that stops microbes from entering or exiting the mask. Surgical Face Masks feature pleats or folds. Three pleats are used to allow the user to expand the mask such that it covers the area from the nose to the chin. The type is ear-loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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