Data / Medical devices / Sterilizer, Ethylene-Oxide Gas
Sterilizer, Ethylene-Oxide Gas (FLF): 8 FDA-registered makers in 2 countries
8 establishments in 2 countries are registered with the FDA to make Sterilizer, Ethylene-Oxide Gas (product code FLF, Class 2, 21 CFR 880.6860). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on November 12, 2020, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FLF
- Device class
- 2
- Regulation
- 880.6860
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Switzerland | 1 |
Makers of Sterilizer, Ethylene-Oxide Gas
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Andersen Sterilizers, Inc. | Haw River, NC, United States | Manufacturer | 3 | November 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Advanced Sterilization Products | Irvine, CA, United States | Manufacturer | 1 | April 3, 2003 | 0 | 3 | 0 | api.fda.gov |
| ASP Global Manufacturing GmbH | Schaffhausen, Switzerland | Manufacturer | 1 | April 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 1 | January 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | January 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| ARC Specialty Products, Balchem Corporation | Green Pond, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 12, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.