Page 45 - Midway Dental Q2 2017
P. 45
Industry
Update
Michigan Dental FDA Issues Ban on Most
Association Gets CON Powdered Gloves ^
Regulations Lifted*
The rule, which goes into effect Jan.
Great news! Effective Dec. 9, the 18, applies to patient examination
state of Michigan has removed its gloves, powdered surgeon’s
EXUGHQVRPH &HUWLÀFDWH RI 1HHG gloves and absorbable powder for
(CON) regulations on dental CT lubricating a surgeon’s glove.
scanners. Now, dental CT scanners
will be regulated just like any “While use of these gloves
other dental imagining machine is decreasing, they pose an
— meaning they need only be unreasonable and substantial risk of
registered with the state through illness or injury to health care provid-
the Licensing and Regulatory Affairs ers, patients and other individuals
Department. The Michigan Dental who are exposed to them, which
Association spent much of the cannot be corrected through new or
year lobbying the CON regulators updated labeling,” the agency said
and state legislators to remove the in a March news release.
scanners from CON regulation.
Grassroots members helped, too. In its summary of the rule, the FDA
also noted that the ban “does
*Originally published by the Michigan Dental not apply to powder used in
Association
the manufacturing process” of
nonpowdered gloves, “where that
powder is not intended to be part
RI WKH ÀQDO ÀQLVKHG JORYHµ DQG VDLG
´ÀQLVKHG QRQSRZGHUHG JORYHV DUH
expected to include no more than
trace amounts of residual powder
from these processes, and the
agency encourages manufacturers
WR HQVXUH ÀQLVKHG QRQ SRZGHUHG
gloves have as little powder as
possible.”
^ Originally published by the American Dental
Association
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