AT THE TIME OF THIS INVESTIGATION THE GLOVE MANUFACTURER HAS REVIEWED THE MANUFACTURING PROCESS TO ENSURE THAT IT IS RUNNING WITH THE VALIDATED PARAMETERS AND WITHIN NORMAL PROCESS CAPABILITY. ALL MANUFACTURING PROCESS CONTROL AND OPERATING PARAMETERS DURING THE PRODUCTION OF THIS LOT WERE WITHIN THE VALIDATED SPECIFICATION AND NO ABNORMALITY WAS FOUND. NO CHANGE WAS MADE TO THE RAW MATERIALS AND SUPPLIERS, COMPOUNDING FORMULATION OR MANUFACTURING PROCESSES DURING THE PRODUCTION OF THIS LOT. THE PRE-SHIPMENT QUALITY INSPECTION AND TESTING OF THIS LOT PASSED ALL INSPECTION AND TESTING REQUIREMENTS PRIOR TO FINAL SHIPMENT RELEASE. THE NEED FOR CORRECTIVE AND/OR PREVENTIVE ACTIONS WILL BE DETERMINED ONCE THE COMPLAINT SAMPLES ARE EVALUATED AND/OR TESTED. THE 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 IN ORDER TO ENSURE GLOVES ARE CONSISTENTLY PRODUCED ACCORDING TO THE REQUIRED SPECIFICATIONS PRIOR TO PACKING AND RELEASE FOR SHIPMENT. IT IS TO BE NOTED THAT SENSITIVITY OF INDIVIDUALS TO LATEX GLOVES MAY BE A FACTOR IN DEVELOPING SKIN IRRITATIONS OR ALLERGIC REACTIONS FROM WEARING SUCH GLOVES.
D
Patient 1
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE CLINICIANS HANDS BROKE OUT FROM USING THE GLOVES. PER THE CUSTOMER, NO SERIOUS INJURY. SHE DID GO TO THE DERMATOLOGIST TO GET TREATED AND WAS GIVEN MEDICATION THAT SHE COULD NOT REMEMBER THE NAME. THE CLINICIAN IS DOING WELL.
N
Patient 1
AT THE TIME OF THIS INVESTIGATION THE GLOVE MANUFACTURER HAS REVIEWED THE MANUFACTURING PROCESS TO ENSURE THAT IT IS RUNNING WITH THE VALIDATED PARAMETERS AND WITHIN NORMAL PROCESS CAPABILITY. ALL MANUFACTURING PROCESS CONTROL AND OPERATING PARAMETERS DURING THE PRODUCTION OF THIS LOT WERE WITHIN THE VALIDATED SPECIFICATION AND NO ABNORMALITY WAS FOUND. NO CHANGE WAS MADE TO THE RAW MATERIALS AND SUPPLIERS, COMPOUNDING FORMULATION OR MANUFACTURING PROCESSES DURING THE PRODUCTION OF THIS LOT. THE PRE-SHIPMENT QUALITY INSPECTION AND TESTING OF THIS LOT PASSED ALL INSPECTION AND TESTING REQUIREMENTS PRIOR TO FINAL SHIPMENT RELEASE. THE GLOVE MANUFACTURER HAD SUBMITTED THE RETURNED GLOVE SAMPLES TO AN ACCREDITED LABORATORY FOR CHEMICAL ACCELERATORS RESIDUAL TEST. THE TEST RETURNED A RESULT OF ND (NOT DETECTED) OR THE CONCENTRATION WAS BELOW THE DETECTABLE LIMIT FOR THE IDENTIFIED CHEMICALS, WHICH APPEARS TO RULE OUT THE PRESENCE OF RESIDUAL CHEMICAL ACCELERATORS ON THE GLOVES THAT COULD POTENTIALLY CAUSE IRRITATION OR ALLERGIC REACTION UPON CONTACT WITH SKIN.? BASED ON THE ABOVE TEST RESULTS THE ROOT CAUSE OF THE FAILURE MODE IS UNABLE TO BE DETERMINED.?THE MANUFACTURER WILL CONTINUE TO ENSURE THAT THE MANUFACTURING PROCESS IS STABLE AS WELL AS CAPABLE, PROCESS OPERATING PARAMETER?ARE CONSTANTLY MONITORED 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.
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)