Data / Medical devices / United States / Safety-Med Products, Inc.
Safety-Med Products, Inc.: FDA-registered device maker in Burlington, WI, United States, 1 510(k) clearance
Safety-Med Products, Inc. is registered with the FDA (registration 3004962765) in Burlington, WI, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 17, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004962765
- Address
- 150 Longmeadow Drive, Burlington, WI, United States, 53105
- Owner or operator
- SAFETY-MED PRODUCTS, INC. (9067562)
- Roles
- Repackager or relabeler
- First device listed
- January 18, 2008
- Registered through
- 2026
- Brand names listed
- Disposable Surgical Mask (sterile, non-sterile); Medical Protective Mask (sterile, non-sterile), Isolation Gown, Protection Plus Earloop Mask, Protection Plus Lab Coat, Protection Plus Stretcher Sheets, RIMEI Level 3 Earloop Mask, Value Plus Earloop Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 17, 2004 | K042654 | PROTECTION PLUS EARLOOP PROCEDURE MASK | FXX | Substantially Equivalent | Safety-Med Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Bedding, Disposable, Medical
- All makers of Accessory, Surgical Apparel
- All makers of Non-Surgical Gown
Updated December 17, 2004. 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.