510(k) K250306

Chex-All Sterilization Pouches and Tubes by Propper Manufacturing Co., Inc. — Product Code FRG

K250306 is an FDA 510(k) premarket notification submitted by Propper Manufacturing Co., Inc. for the device "Chex-All Sterilization Pouches and Tubes". The FDA issued a decision of Substantially Equivalent on October 31, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Propper Manufacturing Co., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2025
Date Received
February 3, 2025
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type