Data / Medical devices / Malaysia / Richter Rubber Technology Sdn. Bhd.
Richter Rubber Technology Sdn. Bhd.: FDA-registered device maker in KUALA KETIL Kedah, Malaysia, 1 510(k) clearance
Richter Rubber Technology Sdn. Bhd. is registered with the FDA (registration 9616559) in KUALA KETIL Kedah, Malaysia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 14, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616559
- FEI number
- 3004063764
- Address
- Plot 209, Kuala Ketil Industrial Estate, KUALA KETIL Kedah, Malaysia, 09300
- Owner or operator
- RICHTER RUBBER TECHNOLOGY SDN. BHD. (9040471)
- Roles
- Manufacturer
- First device listed
- January 3, 2008
- Registered through
- 2026
- Brand names listed
- Here We Flo - XO! Hi-Sensation, Here We Flo - XO! Preservatifs Sensations Fortes, Here We Flo - XO! Preservatifs Ultra-Fins, Here We Flo - XO! Ultra Thin, Here We Flo - XO! Ultra-Resistants, Inspire Impact LLC - Inspire Standard, Inspire Impact LLC - Inspire Ultra Thin, Lovative Pte.Ltd. - Glyde Maxi and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | 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 14, 2008 | K070511 | RICHTER MALE LATEX CONDOM | HIS | Substantially Equivalent | Richter Rubber Technology Sbn Bhd | accessdata.fda.gov |
Compare with other makers
Updated January 14, 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.