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Verify Specialty Labeling Claims

John Calhoun

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Medical examination gloves can possess labeling claims that call attention to certain attributes.  Some of these claims cite basic characteristics, such as material, color and thickness, or that the gloves were manufactured using a powder-free process.  Other claims declare special characteristics or qualities that increase the glove’s value in the marketplace.  These types of claims usually involve reduced chemical sensitization, flavor, low protein, and chemotherapy drug use.

Manufacturers and suppliers of medical examination gloves who wish to publish such claims can do so only after receiving clearance from the Food and Drug Administration (FDA).  Because attributes can affect the safety and effectiveness of gloves, FDA requires the submission of supporting evidence that establishes their validity. Certain requirements must be met before FDA permits these claims. Only after review and clearance by FDA can a glove be advertised or labeled to possess such attributes.  The FDA prohibits labeling that is false or misleading in any way.  Labeling claims should describe the device truthfully and accurately.

Many gloves offered by Sempermed® are powder-free, which means that they meet certain minimum requirements for powder residuals. For example,   Polymed® latex gloves are considered low-protein, indicating that data was submitted to FDA to support reduced levels of water soluble latex proteins in the finished gloves.  SemperSure™ nitrile gloves possess a claim of “low dermatitis potential,” reflecting their diminished risk of causing skin reactions in wearers and patients who are sensitive to certain chemicals frequently used during the manufacturing process.  Several nitrile gloves offered by Sempermed® carry chemotherapy labeling claims, these brands include: Tender Touch® , SemperSure™, SemperShield® , and SemperCare® nitrile.  The gloves were tested against a required series of cytotoxic drugs and the supporting data were submitted to FDA.  All Sempemed® medical examination gloves which possess attribute labeling claims have been cleared by FDA for such claims.

When choosing the appropriate glove, it is important to ensure that all attributes associated with the glove’s labeling are supported by laboratory test data and properly cleared by FDA. Be sure to request supporting documentation from your glove provider.