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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.

JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs. The tested chemotherapy drugs and their breakthrough detection times are as follows: | Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time | |-----------------------------------------------|-------------------------------------| | Carmustine (BCNU) (3.3 mg/ml) | 23.8 Minutes | | Carboplatin (10 mg/ml) | >240 Minutes | | Cisplatin (1 mg/ml) | >240 Minutes | | Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | | Dacarbazine (10.0 mg/ml) | >240 Minutes | | Doxorubicin HCl (2 mg/ml) | >240 Minutes | | Etoposide (20 mg/ml) | >240 Minutes | | Fluorouracil (50 mg/ml) | >240 Minutes | | Ifosfamide (50 mg/ml) | >240 Minutes | | Methotrexate (25 mg/ml) | >240 Minutes | | Mitomycin C (0.5 mg/ml) | >240 Minutes | | Mitoxantrone (2 mg/ml) | >240 Minutes | | Paclitaxel (6 mg/ml) | >240 Minutes | | Thiotepa (10 mg/ml) | 24.1 Minutes | | Vincristine Sulfate (1 mg/ml) | >240 Minutes | Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes Warning: Do not use with Carmustine or Thiotepa.

The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

A powder-free patient examination glove 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included. WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA

Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs

This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin, 1.0 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) Dacarbazine, 10.0 mg/ml (10,000 ppm) Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) Etoposide, 20.0 mg/ml (20,000 ppm) Fluorouracil, 50.0 mg/ml (50,000 ppm) Paclitaxel, 6.0 mg/ml (6,000 ppm) Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes WARNING: Do not use with Carmustine and Thiotepa

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin, 1.0 mg/ml (1,000 ppm) >240 min. Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) >240 min. Dacarbazine,10.0 mg/ml (10,000 ppm) >240 min. Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) >240 min. Etoposide, 20.0 mg/ml (20,000 ppm) >240 min. Fluorouracil,50.0 mg/ml (50,000 ppm) >240 min. Paclitaxel,6.0 mg/ml (6,000 ppm) >240 min. Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7 min. ThioTepa10.0 mg/ml (10,000 ppm), 56.9 min Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7minutes ThioTepa10.0 mg/ml (10.000 ppm),56.9 minutes WARNING: Do not use Carmustine and Thiotepa

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This device is intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin, 1.0 mg/ml (1,000 ppm); Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm); Dacarbazine, 10.0 mg/ml (10,000 ppm); Doxorubicin HCI, 2.0 mg/ml (2,000 ppm); Etoposide, 20.0 mg/ml (20,000 ppm); Fluorouracil, 50.0 mg/ml (50,000 ppm); Paclitaxel, 6.0 mg/ml (6,000 ppm). Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3.300 ppm), 23.9minutes; ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes. WARNING: Do not use Carmustine and Thiotepa

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. 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(2019)

Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Busulfan, 6 mg/ml (6,000 ppm) Carboplatin /Paraplatin, 10 mg/ml (10,000 ppm) Cisplatin, 1.0 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) Cytarabine HCI, 100 mg/ml (100,000 ppm) Dacarbazine, 10.0 mg/ml (10,000 ppm) Docetaxel, 10 mg/ml (10,000 ppm) Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) Etoposide, 20.0 mg/ml (20,000 ppm) Fluorouracil, 50.0 mg/ml (50,000 ppm) Ifosfamide, 50 mg/ml (50,000 ppm) Mechlorethamine HCI, 1 mg/ml (1,000 ppm) Methotrexate, 25 mg/ml (25,000 ppm) Mitomycin, 0.5 mg/ml (500 ppm) Mitoxantrone, 2 mg/ml (2,000 ppm) Paclitaxel, 6.0 mg/ml (6,000 ppm) Vincristine Sulfate, 1 mg/ml (1,000 ppm) Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes WARNING: Do not use Carmustine and Thiotepa

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.