PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
FDA 510(k) K242208 · Primed Medical Products, Inc.
510(k) numberK242208
Submission
- Device name
- PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- Applicant
- Primed Medical Products, Inc.
Edmonton, CA - Received
- July 29, 2024
- Decision date
- October 7, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | Propper Manufacturing Co., Inc. | 10/31/2025SE |
| 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 |
More from Turbett Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K262007 | PRIMED AAMI Level 3 Open Back GownsQPC · Traditional | 09/11/2026SE |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…QSO · Traditional | 09/01/2026SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | 11/04/2025SE |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure MasksFXX · Traditional | 08/26/2024SE |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 05/24/2024SE |
| K213427 | PRIMED Pediatric FacemaskOXZ · Traditional | 11/22/2022SE |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC · Traditional | 11/04/2016SE |
| K092012 | Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model…FXX · Special | 09/25/2009SE |
| K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksFXX · Special | 08/11/2008SE |
Questions and answers
When was PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) cleared by the FDA?
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K242208) received a 510(k) decision of Substantially Equivalent on October 7, 2024, 70 days after the submission was received.
What is the product code of K242208?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.