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510(k) Data Aggregation

    K Number
    K181788
    Device Name
    Lead-free Chemical Indicators for Steam Sterilization
    Date Cleared
    2019-03-01

    (239 days)

    Product Code
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kem Medical Products Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below: *Gravity: 121 C/250 F - 30 minutes (wrapped/porous) *Gravity: 132 C/270 F - 3 minutes (unwrapped/nonporous) *Gravity: 132 C/270 F - 15 minutes (wrapped/porous) *Gravity: 135 C/275 F - 3 minutes (unwrapped/nonporous) * Gravity: 135 C/275 F - 10 minutes (wrapped/porous or unwrapped/nonporous, mixed load) * Vacuum assisted (prevacuum): 132 C/270 F - 3 minutes (unwrapped/nonporous) * Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes (wrapped/porous) * Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes (wrapped/porous) * Vacuum assisted (prevacuum): 135 C/275 F - 3 minutes (wrapped/porous or unwrapped/nonporous, mixed load)
    Device Description
    The Kem Medical Lead-free Chemical Indicators for Steam Sterilization provide immediate confirmation of the sterilization process. The indicator ink is lead-free and can be printed onto suitable paper substrates. As an example, the ink is printed onto adhesive-coated paper for autoclave labels, or "dots", which are removed from a poly or paper backing for use.
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