Propper Sharpguard & Traypad Steril. Aid
FDA 510(k) K802428 · Propper Mfg. Co., Inc.
510(k) numberK802428
Submission
- Device name
- Propper Sharpguard & Traypad Steril. Aid
- Applicant
- Propper Mfg. Co., Inc.
Mchenry, IL, US - Received
- October 6, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K111453 | Steam Dot Blu Process IndicatorJOJ · Abbreviated | 04/05/2012SE |
| K102894 | Classix Chemical Sterilization IndicatorJOJ · Abbreviated | 05/25/2011SE |
| K082620 | Once-A-Day Vertos Test PackJOJ · Abbreviated | 07/08/2009SE |
| K031152 | Propper Vapor Line PCD (Steam Sterilization Process Challenge Test)JOJ · Traditional | 08/17/2004SE |
| K991618 | Bi-O.K. Self-Contained Biological IndicatorFRC · Traditional | 01/24/2001SE |
| K991276 | Pass/Fail Challenge PackJOJ · Traditional | 07/12/1999SE |
| K973585 | Propper Eo Line Ethylene Oxide Sterilization IntegratorJOJ · Traditional | 11/06/1998SE |
| K972747 | Bi-O.K. Eo Gas Biological Test-Pak (269305,269310,269320)FRC · Traditional | 01/09/1998SE |
| K961156 | Once-A-Day Bowie and Dick Test Pack.JOJ · Traditional | 04/01/1997SE |
| K921798 | Propper Super Seracult(R)KHE · Traditional | 10/05/1992SE |
Questions and answers
When was Propper Sharpguard & Traypad Steril. Aid cleared by the FDA?
Propper Sharpguard & Traypad Steril. Aid (K802428) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 17 days after the submission was received.
What is the product code of K802428?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.