On December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final ruling banning powdered surgical gloves and powdered examination (medical) gloves, effective January 18, 2017.
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 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 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.” (View the final FDA ruling )
These risks include healthcare 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.
Could this ban affect gloves used in other industries?
The level and types of risk presented by powdered gloves varies depending on the composition and intended use of the glove. Powdered gloves used in food handling do not make direct contact with the consumer, so do not pose the same risk of illness, however, all wearers of powdered gloves will be subjected to the same potential risks.
Why take the risk of using powdered gloves, particularly powdered vinyl gloves, with all their associated health problems?
Non-powdered gloves offer the same level of protection, dexterity and performance, without the risks associated with powdered gloves.
Eagle’s medical nitrile gloves offer further user and customer protection, being latex free, having a low dermatitis potential and protection against fentanyl.
Contact our team of Eagle Protect glove experts to learn more about this FDA law as well as safe alternatives to protect your business.
