Data / Medical devices / China / Dalian Latex Co Ltd
Dalian Latex Co Ltd: FDA-registered device maker in Dalian Liaoning, China, 1 510(k) clearance
Dalian Latex Co Ltd is registered with the FDA (registration 3003999964) in Dalian Liaoning, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 24, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003999964
- Address
- No. 18, Haixing Road,Pulandian District, Dalian Liaoning, China, 116200
- Owner or operator
- Dalian Latex Co Ltd (10027528)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 17, 2008
- Registered through
- 2026
- Brand names listed
- Blowdom, KAPEET, KAPOOT, MALE LATEX CONDOM, NACH, NACH KODEX, Plain/Ribbed/Dotted/Rib&Dot/Physical Delay/Comfort,condoms, Presa and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 24, 2008 | K081413 | TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Dailian Latex Company, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 24, 2008. 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.