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The Disposable Medical Mask 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 use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device. This product contains no components made from natural rubber latex.

Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Busulfan, 6 mg/ml (6,000 ppm) Carboplatin /Paraplatin, 10 mg/ml (10,000 ppm) Cisplatin, 1.0 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) Cytarabine HCI, 100 mg/ml (100,000 ppm) Dacarbazine, 10.0 mg/ml (10,000 ppm) Docetaxel, 10 mg/ml (10,000 ppm) Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) Etoposide, 20.0 mg/ml (20,000 ppm) Fluorouracil, 50.0 mg/ml (50,000 ppm) Ifosfamide, 50 mg/ml (50,000 ppm) Mechlorethamine HCI, 1 mg/ml (1,000 ppm) Methotrexate, 25 mg/ml (25,000 ppm) Mitomycin, 0.5 mg/ml (500 ppm) Mitoxantrone, 2 mg/ml (2,000 ppm) Paclitaxel, 6.0 mg/ml (6,000 ppm) Vincristine Sulfate, 1 mg/ml (1,000 ppm) Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes WARNING: Do not use Carmustine and Thiotepa

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.