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A Sterile Nitrile Surgical Gloves Powder Free is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Sterile Nitrile Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of synthetic rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type II - gloves compounded from synthetic rubber latex. The proposed device is Sterile Nitrile Surgical Gloves Powder Free, and is produced in sizes 6, 6 ½, 7, 7 ½, 8, 8 ½, and 9. All sizes share the same White color. The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10-6 while packaged to maintain sterility. The shelf life is 3 years.

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate 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 and Fentanyl Citrate 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 and Fentanyl Citrate. 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 device is available in Small, Medium, Large and Extra Large sizes. 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)

Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free and Non-Sterile.

Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves Powder Free-Black are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free and non-sterile.

Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are available in Orange & Purple color and are powder free and are provided non-sterile. These gloves have a shelf life for 3 years.

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).

JR Medic 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 examination 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) | 35.0 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) | 64.9 Minutes | | Vincristine Sulfate (1 mg/ml) | >240 Minutes |

The subject device in 510(K) notification is JR Medic 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)

A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, JR Medic Latex Surgeon's Gloves Sterile Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white. The proposed device is sterilized using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are blue in color and are powder free.