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510(k) Data Aggregation
K Number
K962605Device Name
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
Manufacturer
Date Cleared
1997-03-11
(252 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
SURGICOT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Pro-Guard Double Duty, like the other wrap products available, is intended to wrap other medical devices for exposure to saturated steam or ethylene oxide sterilization processes and to maintain sterilization for a reasonable time under reasonable conditions.
Device Description
Pro-Guard Double Duty joins two of these materials, polyester/cellulose and polypropylene, through the ultrasonically bonding of a sheet of one to a sheet of the other. This provides the traditional two sheets of wrap but allows the user to wrap the tray or pack with both sheets at the same time as in the Kimberly-Clark One Step product rather than sequentially. No additional materials are added as a bonding agent or for any other reason. Sheets of two different materials were used rather than two sheets of the same material in an effort to provide the best characteristics of each for the end user. The cellulose/polyester (Pro-Guard) is used as the outside sheet for its non-irritating handling properties and good biobarrier characteristics and 100% polypropylene is used on the inside as a strengthening member with its resistance to tear. Both materials are non toxic when used as directed for the purpose intended. The resulting product is puncture resistant, offers the same biobarrier qualities as other premium wrap products while allowing the user to save time by wrapping an item intended for sterilization once rather than twice.
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