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510(k) Data Aggregation

    K Number
    K241836
    Device Name
    Kem Medical Lead-free Chemical Indicators for Steam Sterilization
    Manufacturer
    Kem Medical Products Corporation
    Date Cleared
    2024-09-30

    (97 days)

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

    Kem Medical Products Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 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. They are Type 1 Process Indicators per ISO 11140-1:2014 Sterilization of healthcare products-Chemical Indicators - Part 1 General Requirements, consisting of chemical indicator ink and paper substrate with a visual color change from light color (white/off-white) to dark color (cocoa/black) when exposed to a steam sterilization process. The Kem Medical Lead-free Chemical Indicators for Steam Sterilization consist of indicator ink printed on a paper substrate with or without adhesive. The indicator ink is lead free. An example of this indicator is the ink printed onto adhesive-coated paper for autoclave labels, or "dots", which are removed from a poly or paper backing for use. Kem Medical manufactures in various shapes and sizes printed on paper substrates with and without adhesive on the underside, and with or without labeling on each individual indicator.
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