Zdrowie i gospodarka · 16.11.1999

Medical Devices; Draft Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves.'' This guidance is neither final nor is it in effect at this time. This guidance describes the information needed to support an expiration date labeling claim for powdered or powder-free, surgeon's or patient examination gloves. Expiration dating of medical gloves is voluntary at this time. FDA recommends that manufacturers, repackagers, or importers who add an expiration date labeling claim follow the enclosed recommended criteria and protocols for conducting testing described in this guidance.