Search Results
Found 1 results
510(k) Data Aggregation
K Number
K181788Device Name
Lead-free Chemical Indicators for Steam Sterilization
Manufacturer
Date Cleared
2019-03-01
(239 days)
Product Code
Regulation Number
880.2800Why 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1