Search Results

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: • Arsenic Trioxide (0.1mg/ml),(100ppm) >240 Minutes • Bleomycin Sulfate (15mg/ml),(15,000 ppm) >240 Minutes • Busulfan(6mg/ml),(6,000 ppm) >240 Minutes • Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) 127.5 Minutes • Cisplatin (1.0mg/ml), (1,000 ppm) >240 Minutes • Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) >240 Minutes • Cytarabine(100mg/ml), (100,000 ppm) >240 Minutes • Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) >240 Minutes • Daunorubicin(5mg/ml), (5,000 ppm) >240 Minutes • Docetaxel(10mg/ml), (10,000 ppm) >240 Minutes • Doxorubicin HCL(2mg/ml),(2,000 ppm) >240 Minutes • Ellence (2mg/ml), (2,000 ppm) >240 Minutes • Etoposide /Toposar (20mg/ml), (20,000 ppm) >240 Minutes • Fludarabine (25mg/ml), (25,000 ppm) >240 Minutes • Fluorouracil(50mg/ml), (50,000 ppm) >240 Minutes • Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) >240 Minutes • Idarubicin (1.0mg/ml), (1,000 ppm) >240 Minutes • Ifosfamide (50mg/ml), (50,000 ppm) >240 Minutes • Irinotecan(20mg/ml), (20,000 ppm) >240 Minutes • Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) >240 Minutes • Melphalan(5mg/ml), (5,000 ppm) >240 Minutes • Methotrexate(25mg/ml),(25,000 ppm) >240 Minutes • Mitomycin C(0.5 mg/ml), (500 ppm) >240 Minutes • Mitoxantrone(2mg/ml),(2,000 ppm) >240 Minutes • Paclitaxel(6.0mg/ml),(6,000 ppm) >240 Minutes • Paraplatin (10mg/ml),(10,000 ppm) >240 Minutes • Rituximab(10mg/ml),(10,000 ppm) >240 Minutes • Thiotepa (10mg/ml),(10,000 ppm) >240 Minutes • Trisenox(0.1mg/ml), (100 ppm) >240 Minutes • Vincristine Sulfate(1.0mg/ml).(1.000 ppm) >240 Minutes Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.

The subject device in this 510(k) Notification is a Purple Nitrile Examination gloves, tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Purple in color, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is a Lavender Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Lavender in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.