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SEMPERGRAMS


May 4, 2016
FDA Proposes Ban on Powdered Gloves
On March 22, 2016, the U.S. Food and Drug Administration (FDA) issued
proposed legislation that would ban powdered surgical gloves and powdered
examination gloves, as well as the absorbable powder used in the manufacture
of powdered surgical gloves. This proposed ruling was published in the Federal
Register (Vol. 81, No. 55) and is available for viewing at the following address:
https://www.gpo.gov/fdsys/pkg/FR-2016-03-22/pdf/2016-06360.pdf
The proposed rule is summarized as follows:
“The Food and Drug Administration (FDA or Agency) has determined that
Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and
Absorbable Powder for Lubricating a Surgeon’s Glove present an unreasonable
and substantial risk of illness or injury and that the risk cannot be corrected or
eliminated by labeling or change in labeling. Consequently, FDA is proposing
these devices be banned.”

Public comments regarding this ban will be accepted until June 20, 2016, after
which the FDA will review the submissions and issue a final rule. It is unknown
when the final rule will be published.
If the proposed ban is approved, manufacturers will not be permitted to market
affected gloves after an effective date, which will be established in the final rule.
All affected gloves must also be removed from the market by the effective date,
after which they will be considered adulterated and unusable.
Mostly in anticipation of an affirmative final rule, Sempermed discontinued its
DERMA plus® powdered surgical gloves on 28 March 2016. Several years ago,
Sempermed discontinued all branded powdered examination gloves.
During the public comment period, Sempermed will encourage the FDA to
develop an appropriate transition period, during which powdered gloves may be
withdrawn from the market without compromising the health and safety of health
care providers. We will also recommend that the duration of this transition
period be sufficient to prevent a market shortage of suitable powder-free
alternatives.
If you need additional information, or assistance on technical issues concerning
Sempermed gloves, please contact our Customer Service representatives at
800-366-9545.