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510(k) Data Aggregation

    K Number
    K141876
    Device Name
    Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
    Manufacturer
    PASTURE PHARMA PTE LTD
    Date Cleared
    2015-10-28

    (474 days)

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

    PASTURE PHARMA PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Pasture F550S and Pasture F550CS respirators are disposable duck bill shaped N95 respirators with NIOSH certification number TC-84A-7504. They contain 5 layers composed of polypropylene, with a nose cushion, a synthetic elastic loop or strap, and a nosepiece which is the combination of zinc wires and embedded polyester inside of layers. F550CS is the same respirator as the F550S, but F550CS contains an adjustable buckle on the headband. Pasture A520S and Pasture A520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7454. They contain 4 layers composed of polypropylene with a synthetic elastic loop or a strap. A520CS is the same respirator as the A520S, but A520CS contains an adjustable buckle on the headband. Pasture E520S and Pasture E520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7453. They contain 4 layers composed of polypropylene with a nose cushion, synthetic elastic loop or strap, and an aluminum nosepiece. E520CS is the same respirator as E520S, but E520CS contains an adjustable buckle on the headband.
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    K Number
    K141875
    Device Name
    Pasture 60S Surgical Mask
    Manufacturer
    PASTURE PHARMA PTE LTD
    Date Cleared
    2015-05-05

    (298 days)

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

    PASTURE PHARMA PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Pasture 60S Surgical Mask is a flat pleated surgical mask. It is in 4 layers and composed of PP and Meltblown, also with elastic loops and nosepiece which is the combination of zinc wires and embedded polyester inside of layers.
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    K Number
    K083176
    Device Name
    PASTURE, MODELS: F550, A520
    Manufacturer
    PASTURE PHARMA PTE LTD
    Date Cleared
    2009-01-23

    (87 days)

    Product Code
    NZJ
    Regulation Number
    880.6260
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASTURE PHARMA PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies - Pasture™ A520G Respirator and Pasture™ F550G Respirator
    Device Description
    Pasture F550G respirator is a duck bill mask as described in NIOSH N95 standard It 1s in 5 layers and composed of spunbond, meltblown and polyester, also with nose cushion, elastic loops and/or strip and nosepiece which is the combination of zinc wires and embedded polyester inside of layers Pasture A520G respirator is a cone shaped mask as described in NIOSH N95 standard It is in 4 layers and composed of spunbond, meltblown and polyester, also with synthetic rubber band which is coated with polyester and free of latex
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