CRITERION N200 POWDER FREE NITRILE EXAM GLOVES

Additional Manufacturer Narrative

AT THIS TIME THE SAMPLES WERE RECEIVED IN (B)(4) ON 2/23/17 AND HAVE BEEN SENT TO THE SUPPLIER FOR EVALUATION. A FOLLOW-UP WILL BE FILED ONCE THE SAMPLE EVALUATION HAS BEEN COMPLETED.

Description of Event or Problem

BASED ON THE CUSTOMERS REPORT, THERE WAS A SHARD OF GLASS INSIDE THE GLOVE, AND IT PIERCED A WOMAN¿S HAND. THE SHARD WAS REMOVED SUCCESSFULLY WITH FORCEPS AND THE WOMAN HAD TO GO TO THE OCCUPATIONAL HEALTH CENTER. THE WOMAN ALSO HAD UNKNOWN BLOOD WORK DONE.

Additional Manufacturer Narrative

BASED ON THE LOT NUMBER PROVIDED, WE REVIEWED THE DEVICE HISTORY RECORD (DHR) AND NO ABNORMALITIES WERE NOTED. ALL MANUFACTURING PROCESS CONTROL 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 PROCESSES DURING THE PRODUCTION OF THIS LOT. PRE-SHIPMENT QUALITY INSPECTION OF THIS LOT PASSED ALL INSPECTION REQUIREMENTS PRIOR TO FINAL SHIPMENT RELEASE.   AN OPENED BOX OF GLOVES FOR THE SAME LOT NUMBER WAS PROVIDED BY THE CUSTOMER FOR EVALUATION.   NO SHARD OF GLASS OR OTHER FOREIGN SUBSTANCE WAS FOUND ON ANY OF THE GLOVES. THEREFORE WE ARE UNABLE TO CONFIRM THE ISSUE REPORTED.  ONGOING PREVENTIVE ACTION ITEMS THAT ARE BEING DONE OR IMPLEMENTED BY THE GLOVE MANUFACTURER TO ELIMINATE OR REDUCE THE RECURRENCE OF SUCH DEFECT ARE AS FOLLOWS: ANY DETECTED INCIDENT OF BROKEN MOLD AT THE PRODUCTION LINE ADJACENT TO PACKING AREA WILL TRIGGER THE BATCH OF GLOVES BEING PACKED AT THE TIME TO BE QUARANTINED AND SORTED PRIOR TO PACKING/REPACKING. COVERING THE EXPOSED SECTION OF THE PRODUCTION LINE ADJACENT TO THE PACKING AREA TO CONTAIN ANY DEBRIS FROM BROKEN MOLDS WITHIN THE ENCLOSED SECTION. PACKING MATERIALS AND GLOVE CONTAINERS SHALL BE STORED OR MAINTAINED PROPERLY TO PREVENT EXPOSURE TO ANY INCIDENTS OF FLYING DEBRIS FROM BROKEN MOLDS AT THE LINE. 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 IN ORDER TO ENSURE GLOVES ARE CONSISTENTLY PRODUCED ACCORDING TO THE REQUIRED SPECIFICATION PRIOR TO PACKING AND RELEASE FOR SHIPMENT.