On December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final ruling banning powdered surgical gloves and powdered examination (medical) disposable gloves, effective January 18, 2017, both Nitrile and Latex gloves.
The effective date applies to gloves already in commercial distribution and those already sold to the end users, as well as to products to be sold or distributed in the future. All powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves must be removed from the market upon the effective date of this final rule.
Any powdered medical gloves remaining on the market after January 18, 2017, including any currently in use by end-users, would be deemed by the FDA to be adulterated and unusable.
This ban does not apply to the powder used in the manufacturing process (e.g. as a former release agent) of powder-free gloves, where the powder is not intended to be part of the final finished glove.
Why has the FDA banned powdered medical examination gloves?
The FDA determined that “the risk of illness or injury posed by powdered gloves is unreasonable and substantial."
These risks include health care worker and patient sensitization to natural rubber latex (NRL) allergens, surgical complications related to peritoneal adhesions, hypersensitivity reactions, allergic reactions (including asthma) and other adverse health events such as inflammatory responses to glove powder.
View the final FDA ruling here.
Could this ban affect the NZ market?
It is likely that this ban will be adopted in New Zealand. The level and types of risks presented by powdered disposable gloves varies depending on the composition and intended use of the glove in the medical setting. Nevertheless, non-powdered gloves offer the same level of protection, dexterity, and performance, without the risks associated with powdered gloves.
Our Sensitive Nitrile disposable gloves offer further user and customer protection, being powder-free, latex-free and accelerator free – specifically designed for people with sensitive skin.