Based on supplier investigation, the device history record could not be reviewed, as the lot number was not provided.No sample was returned for the investigation.There is no occurrence reported in the past 12 months.No changes have been made to the manufacturing process and product formulation of the affected product.Supplier confirmed their product formulation does not contain any dialkylthioureas.Supplier initiated ph test on the retained samples from a random good shipment.The ph test had been conducted on 3 pieces of retained samples to determine the ph value of the gloves.The ph test results show that the gloves¿ ph values are within specification.Supplier had reviewed the biocompatibility test report (iso (b)(4) animal irritation test and dermal sensitization assay test) for the affected product.The tests concluded that the gloves were non-irritant and non-sensitizing.Based on the investigation and analysis made on the retained samples, no abnormality was found that could lead to the reported issue.All testing conducted proved that the gloves conform to the quality requirements.The root cause could not be determined for this case.No action will be taken at this time, we will continue to monitor for trends.
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