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FLEXAL™ Nitrile exam gloves are our best-selling exam gloves in our High Use portfolio. They provide tactile sensitivity and protects hands from potentially infectious materials.* They are available in a premium packaging configuration- Flexal™ with dispensing film.

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FDA Registration of Latex and Nitrile gloves - fdahelp.us

16 行·FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even …

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Recognized Consensus Standards

Dec 23, 2019·The FDA does not recognize this/these clause(s) in this standard because Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public …

Device common or usual name : NITRILE EXAMINATION GLOVE FDA Device Class : Class 1 Product Code : LZA 4. Identification of the Device : Class I patient Examination Nitrile gloves, Powder Free, LZA, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.

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US FDA Medical Device Labeling Requirements - Gloves

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Exam Gloves - Ansell

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Medical Gloves for COVID-19 | FDA

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