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510(k) Data Aggregation

    K Number
    K230707
    Device Name
    Skypro, Surgical Gown 6021
    Manufacturer
    Skypro Medical Supplies Company
    Date Cleared
    2023-10-12

    (212 days)

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

    Skypro Medical Supplies Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
    Device Description
    "Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back. "Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
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    K Number
    K202255
    Device Name
    Skypro, SP02 Mask (3)
    Manufacturer
    Skypro Medical Supplies Company
    Date Cleared
    2021-12-24

    (501 days)

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

    Skypro Medical Supplies Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Skypro, SP02 Mask (Level 3)" is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended for infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.
    Device Description
    "Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.
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    K Number
    K152197
    Device Name
    Skypro, SP01 Mask
    Manufacturer
    Skypro Medical Supplies Company
    Date Cleared
    2016-08-26

    (387 days)

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

    Skypro Medical Supplies Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skypro, SP01 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 of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
    Device Description
    Skypro, SP01 Mask, is a flat pleated procedure or surgical mask. It is 3 layers and composed of Polypropylene and Meltblown, with elastic earloops or Ties in either knitted polyester/lycra or non-woven polyester and A malleable nosepiece is placed within the bindings for comfort and individualized fir around the wearer's nose.
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