The ruling marks only the second time in history that the FDA has banned a medical device
The much awaited ban on dangerous powdered medical gloves will come into effect on January 19, 2017. The agency first proposed the ban back in March 2016 and issued a final ruling December 16, 2016.
This ban can be termed as one of the best New Year resolution taken by worlds largest US-based regulator. The ruling marks only the second time in history that the FDA has banned a medical device. The only other time the agency has banned a medical device was in 1983, when it banned prosthetic hair fibers.
The FDA determined that simply adding a warning label to powdered gloves was not enough to address the risk, the agency said. “While medical gloves play a significant role in protecting patients, health care providers and other individuals in close proximity, powdered gloves are dangerous for a variety of reasons,” the FDA said in a statement.
Ansell, a global leader in hand barrier protection segments, spearheads India and sub continent region with extensive powder free gloves portfolio. With an eye on futuristic clinical needs, the organisation also provides even safer solutions in the form of non latex powder free surgical and examination gloves.
Hundreds of surgeons in India also participated in signature campaign in support of US FDA ban on powdered medical gloves. This campaign was organised at annual conference of surgeon and orthopedics in India which was collectively attended by almost 8000 delegates.
Ansell has taken an initiative to start making healthcare powder free in India, Pakistan, Sri Lanka, Bangladesh and Maldives. The region has started adapted powder free practice but marginally. Alke US, we also expect regulators out here to ban such clinically hazardous powdered medical gloves.