Recent seizures of more than 47 million imported latex medical gloves with defect rates as high as 91 percent led FDA to propose for the first time a regulation setting a maximum defect level for patient examination and surgeons' gloves, instead of acting on a case-by-case basis.
Concern about the quality of patient examination and surgeons' gloves has heightened since the advent of AIDS. Health-care workers rely on latex as a protective barrier against possible transmission of the AIDS virus. In response to this concern, FDA in September 1988 began a five-month survey and sampling program for medical gloves.
An FDA investigation in Cleveland, Ohio, and in Indianapolis, Ind., led to seizure of 1.72 million imported patient gloves valued at more than $85,000. Cincinnati district investigator Frederick Lochner says that since the demand for medical gloves has increased, the number of shipments of imported gloves has burgeoned.
FDA issued an import alert on foreign companies whose products the agency found defective in its survey. Lochner traced a shipment from one of these companies-P.T. Indotama Megah Indah Rubber, Indonesia-to Cypress Corporation, a Cleveland distributor. FDA visited Cypress and took 100 gloves to sample for defects; 21 had pinhole-sized leaks. Cypress told the agency that another lot of 500 cases-totaling 1 million gloves-from Indonesia had been sent to Midwest Hospital Supply in Indianapolis.
Patricia Cochran, an FDA inspector in the Indianapolis office, …