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The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The tested chemotherapy drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min Carboplatin (10.0 mg/ml 10,000 ppm) >240 min Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2 Cisplatin (1.0 mg/mL 1,000 ppm) >240 min Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min Idarubicin (1.0 mg/ml 1.000 ppm) >240 min Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min Methotrexate (25.0 mg/mL 25,000 ppm) >240 min Mitomycin C (0.5 mg/mL 500 ppm) >240 min Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min Thiotepa (10.0 mg/mL 10,000 ppm) 13.1 Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min The tested non-chemotherapy drugs are: Fentanyl Citrate Injection (100 mcg/2mL) >240 min MESNA (100.0 mg/mL 100,000 ppm) >240 min Trisenox (1.0 mg/ml 1,000 ppm) >240 min Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.

The Medical 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.

The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device is manufactured with three layers, 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 proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.