Cleared Abbreviated

Chex-All Sterilization Pouches and Tubes

K250306 · Propper Manufacturing Co., Inc. · General Hospital
Oct 2025
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K250306 is an FDA 510(k) clearance for the Chex-All Sterilization Pouches and Tubes, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on October 31, 2025, 270 days after receiving the submission on February 3, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K250306 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2025
Decision Date October 31, 2025
Days to Decision 270 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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