FDA Ban on Powdered Gloves
On January 18, 2017 the Food and Drug Administration (FDA) added Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove to their list of banned medical devices.
This ban has created some confusion regarding the use of these gloves in research laboratories so I hope to clarify who is impacted by this ban.
First, this ban applies to gloves being used as medical devices on living subjects, not as personal protective equipment. For example, as of January 18, 2017 our practicing dental and health care clinicians who are coming in direct contact with patients are prohibited from using these gloves and must also dispose of any they have available for use.
Second, this ban also applies to veterinarians and other animal clinicians working on living animal subjects. The FDA’s Center for Veterinary Medicine issued an update to ensure veterinary stakeholders are aware that the ban applies to all powdered medical gloves used in the practice of veterinary medicine, except powdered radiographic protection gloves.
Finally, devices such as gloves used solely for research, teaching or chemical analysis are not subject to section 516 of the FD&C Act (21 U.S.C. 360f), which provides the statutory authority to ban devices within FDA's authority to regulate such products. The third exclusion listed in the Exclusions from application of section in 21 U.S.C. 360f is “persons who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in research, teaching, or chemical analysis and not for sale”. This is also clarified in the answer to question 13 found within the comments listed in the FDA ban.
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