Data / Medical devices / United States / Duogreen Inc.
Duogreen Inc.: FDA-registered device maker in Fort Lee, NJ, United States, 2 510(k) clearances
Duogreen Inc. is registered with the FDA (registration 3013023150) in Fort Lee, NJ, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 2, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013023150
- Address
- 2460 lemoine Ave 302, Fort Lee, NJ, United States, 07024
- Owner or operator
- Duogreen Inc. (10060228)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 9, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | 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 |
|---|---|---|---|---|---|---|
| May 2, 2003 | K030207 | NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 | LZA | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| July 23, 2002 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Respirator, Surgical
- All makers of Polymer Patient Examination Glove
Updated May 2, 2003. 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.