Data / Medical devices / Indonesia / PT. Haloni Jane
PT. Haloni Jane: FDA-registered device maker in CIKUPA, TANGERANG Banten, Indonesia, 1 510(k) clearance
PT. Haloni Jane is registered with the FDA (registration 9680775) in CIKUPA, TANGERANG Banten, Indonesia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 9, 2006. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9680775
- FEI number
- 3004040517
- Address
- Jalan Raya Serang KM. 13.8, CIKUPA, TANGERANG Banten, Indonesia, --
- Owner or operator
- PT. HALONI JANE (9011326)
- Roles
- Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2027
- Brand names listed
- Shamrock
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 |
|---|---|---|---|---|---|---|
| November 9, 2006 | K062955 | POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE | LYY | Substantially Equivalent | Pt. Haloni Jane | accessdata.fda.gov |
Compare with other makers
Updated November 9, 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.