Data / Medical devices / Malaysia / Betelcare Sdn Bhd
Betelcare Sdn Bhd: FDA-registered device maker in Kapar Selangor, Malaysia, 1 510(k) clearance
Betelcare Sdn Bhd is registered with the FDA (registration 8040910) in Kapar Selangor, Malaysia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 5, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8040910
- FEI number
- 3366
- Address
- Lot 3342, Jalan Keretapi Lama, 7 1/2, Off Jalan Kapar, Kapar Selangor, Malaysia, 42200
- Owner or operator
- BETELCARE SDN BHD (10077738)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 17, 2020
- Registered through
- 2026
- Brand names listed
- BETEL GLOVES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | 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 |
|---|---|---|---|---|---|---|
| March 5, 2008 | K073299 | BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE | LYY | Substantially Equivalent | Betel Care Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated March 5, 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.