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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2019).

The subject device in this 510(k) Notification is Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate, Powder Free & Non sterile Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves & ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The available sizes of the subject devices are Small, Medium, Large, X-Large.

This non-powdered 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.

The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.

This non-powdered 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.

The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is 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. The available sizes of the subject devices are Small, Medium, Large, X-Large.