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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY 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 | Minimum Breakthrough Detection Time | |---------------------------------------------------|-------------------------------------| | · Blenoxane (15mg/ml),(15,000 ppm) | >240 Minutes | | · Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes | | · Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 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 (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) | 15.9 Minutes | | · Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes | | · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes | Please note that Carmustine and Thiotepa have extremely low permeation times of 3,6 minutes, respectively WARNING: Do Not Use With : Carmustine, ThioTEPA

The subject device in this 510(k) Notification is a Purple Nitrile Examination glove tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Purple 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 TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Grey Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

Brightway ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Grey Color)

BRIGHTWAY™ Brand Nitrile Examination Glove ( Powder Free, Chlorinated, Black Color ) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

BRIGHTWAY™ Brand Nitrile Examination Gloves (Powder Free, Chlorinated, Black Colour)

BRIGHTWAY™ Brand Latex Examination Glove ( Powder Free, Black Color ) containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

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BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, sterile) containing 150 ugm or less of water extractable protein per gram is a disposable patient examination glove made of Natural Rubber which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.

BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, Sterile) Containing 150 ugm or less of water extractable protein per gram.

for the indications for use stated in the enclosure

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Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.

Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange)

examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner and also to protect the examiner's hands from being affected by the chemicals used in therapy. This glove is to be used in a Non Sterile environment.

BRIGHTWAY TM Brand Powder Free Latex Examination Gloves Blue Color, Non-Sterile ( containing 50 ugm or less of water extractable protein per gram.) (tested for use with Chemotherapy Drugs, Carmustine, Fluorouracil, Methotrexate)