Data / Medical devices / Malaysia / Innolatex Sdn. Bhd
Innolatex Sdn. Bhd: FDA-registered device maker in PORT KLANG Selangor, Malaysia, 7 510(k) clearances
Innolatex Sdn. Bhd is registered with the FDA (registration 9616515) in PORT KLANG Selangor, Malaysia. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated February 21, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616515
- FEI number
- 3003117682
- Address
- Lot 591 & 594, Persiaran Raja Lumu Pandamaran Industrial Estate, PORT KLANG Selangor, Malaysia, 42000
- Owner or operator
- INNOLATEX SDN. BHD (9042429)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 15, 2007
- Registered through
- 2026
- Brand names listed
- CAMO, CAUTION WEAR, CAUTION WEAR BLACK ICE, CAUTION WEAR CLASSIC, CAUTION WEAR GRANDE, CAUTION WEAR SLIPPERY WHEN WET, CAUTION WEAR WILD ROSE, CONDUMB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| February 21, 2006 | K053367 | MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| September 24, 2004 | K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012962 | DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| June 15, 2001 | K010919 | MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| December 19, 2000 | K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
Compare with other makers
Updated February 21, 2006. 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.