Chex-All Sterilization Pouches and Tubes
FDA 510(k) K250306 · Propper Manufacturing Co., Inc.
510(k) numberK250306
Submission
- Device name
- Chex-All Sterilization Pouches and Tubes
- Applicant
- Propper Manufacturing Co., Inc.
Long Island, NY, US - Received
- February 3, 2025
- Decision date
- October 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRG – Wrap, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code FRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional | O&M Halyard, Inc. | 07/02/2026SE |
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | Dukal, LLC | 05/28/2026SE |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 05/18/2026SE |
| K251347 | Sterilization Pouch/RollFRG · Traditional | Sterivic Medical Co., Ltd. | 01/28/2026SE |
| K251177 | Self-Seal Sterilization Pouch and RollFRG · Traditional | Guangdong Maidi Medical Co., Ltd. | 12/12/2025SE |
| K243179 | Sterilization Pouch and RollFRG · Traditional | Yichang Xinxin Paper Products Co., Ltd. | 06/26/2025SE |
| K250321 | GCI Sterilization WrappersFRG · Traditional | George Courey, Inc. | 06/06/2025SE |
| K243721 | Self Sealing Sterilization PouchesFRG · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 04/25/2025SE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional | Turbett Surgical | 04/04/2025SE |
| K241565 | Sterilization Package/ReelFRG · Traditional | Anqing Clean Dental Instrument Technology Co.… | 02/24/2025SE |
More from Anqing Clean Dental Instrument Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240910 | EO Chex Indicator TapeJOJ · Abbreviated | 06/12/2024SE |
| K222137 | OK Plus IndicatorJOJ · Abbreviated | 12/05/2022SE |
| K212592 | Gas-Chex IndicatorJOJ · Abbreviated | 01/20/2022SE |
| K210866 | Steri-Dot Process IndicatorJOJ · Abbreviated | 06/21/2021SE |
| K210553 | Steam-Dot Process IndicatorJOJ · Abbreviated | 05/19/2021SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | 09/17/2014SE |
Questions and answers
When was Chex-All Sterilization Pouches and Tubes cleared by the FDA?
Chex-All Sterilization Pouches and Tubes (K250306) received a 510(k) decision of Substantially Equivalent on October 31, 2025, 270 days after the submission was received.
What is the product code of K250306?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.