Data / Medical devices / Malaysia / Nulatex Sdn. Bhd.
Nulatex Sdn. Bhd.: FDA-registered device maker in Kluang Johor, Malaysia, 2 510(k) clearances
Nulatex Sdn. Bhd. is registered with the FDA (registration 3006799339) in Kluang Johor, Malaysia. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 7, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006799339
- Address
- Lot 1870 4th Miles, Jalan Mengkibol, Kluang Johor, Malaysia, 86000
- Owner or operator
- Nulatex Sdn. Bhd. (10023188)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 23, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 7, 2014 | K132107 | MALE LATEX CONDOM | HIS | Substantially Equivalent | Nulatex Sdn. Bhd. | accessdata.fda.gov |
| February 14, 2013 | K121241 | MALE LATEX CONDOM | HIS | Substantially Equivalent | Nulatex Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated March 7, 2014. 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.