510(k) K260181

LF Process Indicator Tape for Steam Sterilization by Intertape Polymer Group — Product Code JOJ

K260181 is an FDA 510(k) premarket notification submitted by Intertape Polymer Group for the device "LF Process Indicator Tape for Steam Sterilization". The FDA issued a decision of Substantially Equivalent on February 20, 2026. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2026
Date Received
January 21, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type