Powdered Surgical Gloves, Gone with the Wind?

March 21, 2016

Powdered Surgical Gloves

Gone with the Wind?

March 21, 2016

 

Cardinal Health recently announced its discontinuation of powdered surgical gloves by mid-2016. In addition, it is rumored that another large US surgical glove supplier has made a similar announcement, and confirmation of that announcement is being sought.

(Note: Mölnlycke Health Care has always supplied ONLY powder-free Biogel® Surgical Gloves in the US)

Those announcements come as the FDA continues to move a proposed powdered surgical ban document through the regulatory system in response to Citizens Petitions. The FDA routed the proposed powder ban document through government agencies and received approval of the surgical glove powder ban.

The next step for the FDA is to post the proposed document for public comment. The FDA has posted the wording for the proposed glove powder ban online at  https://www.federalregister.gov/documents/2016/03/22/2016-06360/banned-devices-proposal-to-ban-powdered-surgeons-gloves-powdered-patient-examination-gloves-and

Then, when the public comment period expires in 90 days , the FDA will assess the comments and determine whether the proposed document should be approved for insertion into the CFR as written, edited or rejected.  

If accepted or edited, the ban will become official and glove powder cannot be used on medical gloves in the US. If rejected, we are back to square one.

In the interim, manufacturers’ ceasing their manufacture of powdered surgical gloves could possibly eliminate the availability thereof. That could happen before the FDA can act on the Citizens’ Petitions to ban surgical glove powder.

One way or another, it appears that surgical glove powder might soon be gone with the wind.

 

Milt Hinsch
Technical Services and Technology Director
Surgical Products 
Mölnlycke Healthcare