When it comes to leak testing for latex products (condoms, medical gloves), FDA is not infallible, and can be challenged. When testing for leak holes in shipments of imported condoms and medical gloves, the Agency adopts a composite sampling method, which increases the chance of a false positive outcome, and thus subjects these shipments to prolonged holds at the port – and, ultimately, refusal of entry into the U.S. market. The only way to avoid this is to understand how FDA sampling works and proactively challenge FDA’s decision.
AQL for Condoms and Medical Gloves Leak Tests
The essential function of condoms and medical gloves is to provide a protective barrier. Therefore, FDA commonly tests these articles to see whether they have leak holes. FDA fills the glove or condom with water for two minutes. If the glove or condom leaks, it fails the test. To determine how many failures can justify an import refusal, FDA designates an Acceptable Quality Level (AQL), measured per lot, specific to each product category: 0.4% for condoms, 1.5% for surgical gloves (worn by operating room personnel to protect against surgical wound contamination), and 2.5% for patient examination gloves (worn by medical examiners).
This means, for example, that FDA can legally refuse a shipment if FDA finds more than 4 leaking condoms per 1,000.
FDA’s Composite Sampling Plan Presents a Problem for Representativeness
FDA collects samples according to its own sampling chart. Due to the large number of gloves or condoms in one shipment, FDA’s surveillance sampling typically consists of collecting samples that include multiple lots, instead of testing each lot specifically. However, given that FDA collects its sample across lots and that the AQL standard is by lot, FDA’s composite sampling creates a question: when the composite samples across lots exceed the AQL, can FDA state that each lot also exceeds the AQL? This leads to false positives and instances where FDA’s sampling can be challengeable.
Industry Needs to Act Proactively to Avoid Commercial Loss
If FDA finds that the sample across the lot exceeds the AQL, then FDA will issue an import refusal. FDA may also place the facility on Import Alert, which means that every shipment from the same facility in the future will be automatically held at port by FDA and only released after providing evidence demonstrating compliance.
The FDAImports.com team has helped clients work with private laboratories to develop independent tests to challenge FDA’s positive sampling result. If you have a latex shipment under FDA surveillance test, let us know. We can help!
