The lot number was not provided, therefore the device history record could not be reviewed.The complaint sample was not available for evaluation, therefore an exact root cause could not be determined.Trending was done.Per historical testing, the protexis pi blue gloves passed the requirements of the primary skin irritation test per the technical service report.The protexis pi blue gloves have passed a series of tests prescribed by regulatory agencies for the intended use.However, the possibility of some individuals experiencing reactions to certain chemicals used during the manufacturing process cannot be ruled out.We will continue to monitor complaints for any unfavorable trends, which might require further investigation.
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Scrub technician developed hand itching, redness, blisters and ulcers.Their symptoms started in february.They wore the gloves for approximately 1 year before developing symptoms.Steroids were followed by seeing a dermatologist and testing for allergies.Back to work 6 weeks later.Discontinued using the gloves.
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