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510(k) Data Aggregation
K Number
K152669Device Name
PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
Date Cleared
2016-01-15
(120 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.
The recommended (and validated) sterilization cycle parameters are;
· For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes.
· For EO sterilization: 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.
Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process.
After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.
Device Description
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the fourth side has a self-seal adhesive strip and left opened. This side is manually sealed by the user with the self-seal adhesive strip. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear. PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are presented as 60 gsm model.
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