CRITERION PURE NITRILE POWDER FREE EXAM GLOVES

Additional Manufacturer Narrative

HISTORICAL TRENDING FOR THE PAST 12 MONTHS WAS COMPLETED AND THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ABNORMALITIES WERE NOTED.  ALL MANUFACTURING PROCESS CONTROLS AND OPERATING PARAMETERS WERE WITHIN THE VALIDATED SPECIFICATION AND NO ABNORMALITY WAS FOUND. NO CHANGE WAS MADE TO THE RAW MATERIALS AND SUPPLIERS, COMPOUNDING FORMULATION, OR MANUFACTURING PROCESS DURING THE PRODUCTION OF THIS LOT. PRE-SHIPMENT QUALITY INSPECTION OF THIS LOT PASSED ALL INSPECTION REQUIREMENTS PRIOR TO FINAL SHIPMENT RELEASE. THE NEED FOR CORRECTIVE AND/OR PREVENTIVE ACTIONS WILL BE DETERMINED ONCE THE COMPLAINT SAMPLE TESTING IS COMPLETED. IT IS TO BE NOTED THAT SENSITIVITY OF INDIVIDUALS TO NITRILE GLOVES MAY BE A FACTOR IN DEVELOPING SKIN IRRITATION OR ALLERGIC REACTION FROM WEARING SUCH GLOVES. THE GLOVE MANUFACTURER WILL CONTINUE TO ENSURE THAT THE MANUFACTURING PROCESS IS STABLE ANS THAT GOOD MANUFACTURING PRACTICES ARE ADHERED TO AND CONTINUOUS IMPROVEMENT STRATEGIES ARE IMPLEMENTED IN ORDER TO ENSURE GLOVES ARE CONSISTENTLY PRODUCED ACCORDING TO THE REQUIRED SPECIFICATION PRIOR TO PACKING AND RELEASE FOR SHIPMENT.

Description of Event or Problem

BASED ON THE REPORT RECEIVED BY OUR CUSTOMER THE DOCTOR STATED THE GLOVES IRRITATED HIS SKIN. HE HAS NEVER USED THIS BRAND OF GLOVES BEFORE. THE DOCTOR WENT TO THE DERMATOLOGIST, HOWEVER THE TREATMENT RECEIVED IS UNKNOWN. ONCE HE STOPPED WEARING THE GLOVES THE IRRITATION WENT AWAY. THE DOCTOR DOES NOT HAVE ANY KNOWN ALLERGIES.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ABNORMALITY WAS NOTED. INSPECTION AND TESTING OF GLOVES FROM THIS LOT AT THE TIME OF RELEASE PRIOR TO SHIPMENT MET ALL REQUIREMENTS AS SPECIFIED FOR THIS PRODUCT. RETURNED COMPLAINT GLOVES DID NOT EXHIBIT ANY VISIBLE ABNORMALITY, PH READING IS CLOSE TO THE NEUTRAL VALUE, NO SKIN IRRITATION WAS REPORTED BY THE GLOVE MANUFACTURING PLANT PERSONNEL FROM DONNING THE GLOVE AT A 2-HOUR STRETCH. RESIDUAL CHEMICAL ACCELERATOR TEST RETURNED A RESULT OF ¿NOT DETECTED¿ OR THE CONCENTRATION WAS BELOW THE DETECTABLE LIMIT, WHICH APPEARS TO RULE OUT THE PRESENCE OF RESIDUAL CHEMICAL ACCELERATORS ON THE GLOVES THAT COULD POTENTIALLY CAUSE IRRITATION UPON CONTACT WITH SKIN. IT IS TO BE NOTED THAT SENSITIVITY OF CERTAIN INDIVIDUALS TO NITRILE GLOVES MAY BE A FACTOR IN DEVELOPING SKIN IRRITATION OR ALLERGIC REACTION FROM WEARING SUCH GLOVES. MANUFACTURING PROCESS WAS REVIEWED BY THE GLOVE MANUFACTURER TO ENSURE IT IS RUNNING WITH THE VALIDATED PARAMETERS AND WITHIN NORMAL PROCESS CAPABILITY. THE GLOVE MANUFACTURER WILL CONTINUE TO ENSURE THAT THE MANUFACTURING PROCESS IS STABLE AS WELL AS CAPABLE, GOOD MANUFACTURING PRACTICES ARE ADHERED TO AND CONTINUOUS IMPROVEMENT STRATEGIES ARE IMPLEMENTED TO ENSURE GLOVES ARE CONSISTENTLY PRODUCED ACCORDING TO THE REQUIRED SPECIFICATION PRIOR TO PACKING AND RELEASE FOR SHIPMENT.