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510(k) Data Aggregation

    K Number
    K222898
    Device Name
    SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
    Manufacturer
    SafeSource Direct, LLC
    Date Cleared
    2022-11-07

    (45 days)

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

    SafeSource Direct, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Not recommended for use with these drugs.
    Device Description
    The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.
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    K Number
    K221134
    Device Name
    Procedure Mask with Ear Loops and Surgical Mask with Ties
    Manufacturer
    SafeSource Direct, LLC
    Date Cleared
    2022-05-19

    (30 days)

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

    SafeSource Direct, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile. The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.
    Device Description
    The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose. The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.
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