On Monday 12/19/16 the FDA published a final rule Docket No. FDA -2015-N-5017 which will ban the following products effective 1/18/17:
1. Powdered Surgeon Gloves (21 CFR 878.4460),
2. Powdered Patient Examination Gloves (21 CFR 880.6250)
3. Absorbable Powder for lubricating a Surgeon gloves. (21 CFR 878.4480).
*The rule applies to all powdered medical gloves except powdered radiographic protection gloves.
After careful evaluation by the FDA, they have determined that the risk of illness or injury posed by powdered gloves is unreasonable and substantial. This rule becomes effective January 18, 2017. Our regulatory team has contacted the FDA regarding expectations and conformance which are outlined below.
What does this mean to Henry Schein Animal Health (HSAH) customers?
All powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves must be removed from the market by January 18, 2017
Customers are instructed to dispose of any powdered exam gloves or powdered surgical gloves in their possession as of January 18, 2017. Please note that HSAH will NOT be accepting any returns of powder gloves. Healthcare providers and facilities are required to adhere to federal and state regulations, including the Occupational Safety and Health Administration standards. Please consult your state for additional handling requirements for disposal of unused powdered gloves.
After January 18, 2017, if you need to receive replacement gloves for unused powered gloves that were purchased from HSAH, please contact your HSAH Inside Sales Representative.
What is HSAH doing to support/help our customers during this transition?
HSAH has placed a stop-sale on all remaining powdered gloves in our catalog and system as of 12/22/16. Effective immediately you will not be able to purchase powdered gloves from HSAH.
Customers who are interested in receiving additional guidance on proposed substitution should contact their Inside Sales Representative directly or call 855-724-3461.
The final rule may be viewed and downloaded at: https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30382.pdf
If you have any further questions, please contact our HSAH regulatory department at email@example.com.