Sterilization Pouch/Roll Made with Tyvek
FDA 510(k) K133838 · Sigma Medical Supplies Corp.
510(k) numberK133838
Submission
- Device name
- Sterilization Pouch/Roll Made with Tyvek
- Applicant
- Sigma Medical Supplies Corp.
Kaohsiung City, TW - Received
- December 18, 2013
- Decision date
- March 11, 2015
- 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 |
|---|---|---|
| K202462 | SIGMA Sterilization Pouch and RollFRG · Abbreviated | 04/23/2021SE |
| K180672 | Sterilization Pouch/Roll Made with TyvekFRG · Abbreviated | 06/06/2018SE |
| K180661 | SIGMA Sterilization Pouch and RollFRG · Abbreviated | 06/05/2018SE |
| K102158 | Sigma Sterilization Pouch & RollFRG · Traditional | 08/02/2011SE |
Questions and answers
When was Sterilization Pouch/Roll Made with Tyvek cleared by the FDA?
Sterilization Pouch/Roll Made with Tyvek (K133838) received a 510(k) decision of Substantially Equivalent on March 11, 2015, 448 days after the submission was received.
What is the product code of K133838?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.