Zdrowie i gospodarka · 30.07.1999

Surgeon's and Patient Examination Gloves; Reclassification

The Food and Drug Administration (FDA) is proposing regulations to reclassify all surgeon's and patient examination gloves as class II medical devices because it believes that general controls are insufficient to provide a reasonable assurance of safety and effectiveness. The reclassified gloves, including those made of natural rubber latex (NRL) or synthetic material, will be regulated in four categories: Powdered surgeon's gloves, powder-free surgeon's gloves, powdered patient examination gloves, and powder-free patient examination gloves. The proposed special controls are in the form of a proposed guidance document entitled ``Medical Glove Guidance Manual,'' which includes recommended protein and glove powder limits, and new label caution statements including protein and powder labeling requirements. FDA is also proposing to require expiration dating. This proposed rule is intended to reduce the adverse health effects from allergic and foreign body reactions caused by the natural latex (NL) protein allergens and glove powder found on surgeon's and patient examination gloves and to reduce the adverse health effects from defects in the barrier integrity and quality of surgeon's an