K250306 is an FDA 510(k) clearance for the Chex-All Sterilization Pouches and Tubes. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K250306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |