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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim; Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |-----------------------------------------|------------------------------------------------| | Carmustine (BCNU) (3.3 mg/ml) | 26.2 | | Cisplatin (1.0 mg/ml) | >240 | | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | | Cytarabine(100 mg/ml) | >240 | | Dacarbazine (DTIC) (10.0 mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | | Etoposide (20.0 mg/ml) | >240 | | Fluorouracil (50.0 mg/ml) | >240 | | Ifosfamide (50.0 mg/ml) | >240 | | Methotrexate (25.0 mg/ml) | >240 | | Mitomycin C (0.5 mg/ml) | >240 | | Mitoxantrone (2.0 mg/ml) | >240 | | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | Thiotepa (10.0 mg/ml) | 59.1 | | Vincristine Sulfate (1.0 mg/ml) | >240 | Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively. Fentanyl Citrate and Concentration Fentanyl Citrate Injection (100 mcg/2ml) Minimum Breakthrough Detection Time in Minutes >240

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous with beaded-cuff, blue or white colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state. These gloves were designed and manufactured per ASTM D6319-10 standard, and tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, and Modified-Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999". The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous (i.e. can be worn on right hand or left hand) with beaded cuff, blue or white colored, single-use disposable devices, that come in five sizes (XS. S. M. L. XL), and supplied in Non-Sterile state. The principle operating characteristic of the device is to prevent contamination between patient and examiner, achieving through conformance of barrier, physical properties and other testing requirements as stated in Section 7.0 of this 510(k) Summary. The gloves are also complied with ASTM D6319-10 and ASTM D5151-11 on water leak test, forming a barrier to prevent contamination between patient and examiner. Testing of the subject device shows it meets the 1.5 AQL for leakage, exceeding ASTM D6319-10 requirement of 2.5 AQL for leakage. The gloves are designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The physical properties of the subject device meet the requirements for tensile strength and elongation (both unaged and aged) in the standard.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded-cuff, black colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state. The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.