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 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM 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 product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows: Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) ● 4.3 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes 10.9 Minutes >240 Minutes - Cisplatin(1.0mg/ml), (1,000 ppm) - Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) - Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) ● - Doxorubicin HCL(2mg/ml),(2,000 ppm) - Etoposide /Toposar (20mg/ml), (20,000 ppm) - Fluorouracil(50mg/ml), (50,000 ppm) - Ifosfamide (50mg/ml), (50,000 ppm) - Mitoxantrone(2mg/ml),(2,000 ppm) - Paclitaxel(6.0mg/ml),(6,000 ppm) - Thiotepa (10mg/ml),(10,000 ppm) - . Vincristine Sulfate(1.0mg/ml),(1,000 ppm) Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes and 10.9 minutes, respectively. Warning: Do not use with Carmustine and Thiotepa.

The subject device in this 510(k) Notification is Sterling/Grey coloured Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Sterling or Grey 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 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, [BLUE] is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.

The subject device in this 510(k) Notification is a Blue Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Blue 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.

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.

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose 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: Test Chemotherapy Drug Name and Concentration - · Carmustine (BCNU) (3.3mg/ml),(3.300 ppm) - · Cisplatin(1.0mg/ml), (1,000 ppm) - · Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) - · Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) - · Doxorubicin HCL(2mg/ml),(2,000 ppm) - · Etoposide /Toposar (20mg/ml), (20,000 ppm) - · Fluorouracil(50mg/ml), (50,000 ppm) - · Ifosfamide (50mg/ml), (50,000 ppm) - · Mitoxantrone(2mg/ml),(2,000 ppm) - · Paclitaxel/Taxol(6.0mg/ml),(6.000 ppm) - · Thiotepa (10mg/ml),(10,000 ppm) - · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes. Minimum Breakthrough Detection Time 5.4 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes >240 Minutes 40.4 Minutes >240 Minutes

The subject device in this 510(k) Notification is a Sterling/Grey Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Sterling or Grev 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 is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves