SAFEGUARDS | HardlinesNO. 075/16
US Food and Drug Administration (FDA) has proposed a ban on powdered patient examination and surgeon’s gloves and absorbable powder for lubricating surgeon’s gloves. The proposal is open for public comments until 20 June 2016.
On 22 March, 2016, the US FDA published a Notice of Proposed Rulemaking (NPR)  that bans the following devices:
- Powdered surgeon's gloves (21 CFR 878.4460)
Powdered patient examination gloves (21 CFR 880.6250)
Absorbable powder for lubricating a surgeon's glove (21 CFR 878.4480)
The FDA has determined that these devices present an unreasonable and substantial risk of illness or injury which cannot be corrected or eliminated by labeling or a change in labeling. The proposed ban would apply to all powdered gloves except powdered radiographic protection gloves. This proposal would not apply to powder used in the production of non-powdered gloves if the powder is not intended to be part of the final finished glove.
Because the existing classification regulations for these device types do not distinguish between powdered and non-powdered versions, FDA is also proposing to amend the descriptions of these devices in the regulations to specify that, if this proposal is approved, these regulations will apply only to non-powdered gloves while the powdered version of each type of glove will be added to 21 CFR 895 Subpart B-Listing of Banned Devices. 
The rationale presented by the NPR explains the FDA position that the benefits of using powdered gloves for ease of removal are small compared to the potential health risks from the powder. The notice also describes that health care industry have been moving away from the use of powdered gloves in the past 15 years. If approved, the ban will apply to devices already in use as well as existing powdered gloves.
The NPR is open for comments from the public until 20 June, 2016. If approved, the final rule will take effect starting 30 days after its publication in the Federal Register.
Throughout our global network of laboratories, we are able to provide a range of services, including consultancy for medical gloves for the US and international markets. Please do not hesitate to contact us for further information.
For enquiries, please contact:
Technical Manager, Consumer and Retail
t: +01 862 233 5775
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