Data / Medical devices / Malaysia / Tan Sin Lian Industries Sdn. Bhd.
Tan Sin Lian Industries Sdn. Bhd.: FDA-registered device maker in MUAR Johor, Malaysia, 2 510(k) clearances
Tan Sin Lian Industries Sdn. Bhd. is registered with the FDA (registration 9617439) in MUAR Johor, Malaysia. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 16, 2003. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9617439
- FEI number
- 3002872520
- Address
- No.1-14, Jalan Indah 2, Taman Indah Jalan Haji Abdullah, MUAR Johor, Malaysia, 84000
- Owner or operator
- TAN SIN LIAN INDUSTRIES SDN. BHD. (9035650)
- Roles
- Manufacturer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- HOWARD BERGER CO., INC, Shield Line
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | 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 16, 2003 | K031335 | POWDER FREE LATEX EXAM GLOVES | LYY | Substantially Equivalent | Tan Sin Lian Industries Sdn. Bhd. | accessdata.fda.gov |
| September 14, 1999 | K992557 | QUALATEX POWDERED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Tan Sin Lian Industries Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated October 16, 2003. 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.