Why are Powdered Nitrile Gloves Banned in the USA For Medical Examination Purposes?

There is a very good reason that powdered Nitrile Gloves should not be allowed to touch exposed tissue especially in healthcare settings.

On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body’s immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications. For a detailed description of the risks that the FDA identified, please refer to the document (FDA Ruling on 19 December 2016) Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove

Powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove are defined as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)). Section 516 of the FD&C Act (21 U.S.C. 360f) authorizes FDA to ban a device if it finds, on the basis of all available data and information, that the device presents substantial deception or unreasonable and substantial risks of illness or injury, which cannot be corrected by labeling or a change in labeling.

Important Notice: If you are a genuine medical provider or facility in need of Medical Gloves , please let us know via email at [email protected] of our network partners who are legitimate CAGE and DUN registered USA companies, have reserved large amounts of gloves for Medical Facilities with some of the top providers of Gloves and can deliver directly by Air to your premises. Or, if you have multiple clinic facilities, individual deliveries to each Clinic or Medical Facility can be arranged.Agents and middlemen are requested to stay away from this offer and not to advertise this offer by adding obscene sales commissions.Reasonable compensation may be given in exceptional circumstances where a sales agent respects our mandate not to inflate the price and can bring on board a proper and deserving end-user who is in urgent need of these gloves.Details of such offers are available at our # Actions Not Words Covid19 Initiative