Data / Medical devices / Italy / Emerson & Co. S.R.L.
Emerson & Co. S.R.L.: FDA-registered device maker in GENOA Genova, Italy, 3 510(k) clearances
Emerson & Co. S.R.L. is registered with the FDA (registration 3001970230) in GENOA Genova, Italy. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 13, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3001970230
- Address
- 10 Piazza Della Vittoria, GENOA Genova, Italy, 16121
- Owner or operator
- EMERSON & CO. S.R.L. (9034974)
- Roles
- Manufacturer
- First device listed
- September 5, 1998
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 13, 2021 | K192933 | Polyisoprene Powder Free, Black Colour Surgical Gloves | KGO | Substantially Equivalent | Emerson & Co. Srl | accessdata.fda.gov |
| January 15, 2016 | K151228 | PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm | KGO | Substantially Equivalent | Emerson & Co. Srl | accessdata.fda.gov |
| December 23, 1998 | K982832 | PROGUARD, RR-1, RR-2 | LZC | Substantially Equivalent | Emerson & Co. Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Medical Glove, Specialty
- All makers of Shield, Protective, Personnel
- All makers of Radiographic Protective Glove
Updated January 13, 2021. 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.