Data / Medical devices / Indonesia / PT. Intan Hevea Industry
PT. Intan Hevea Industry: FDA-registered device maker in MEDAN Sumatera Utara, Indonesia, 3 510(k) clearances
PT. Intan Hevea Industry is registered with the FDA (registration 8041092) in MEDAN Sumatera Utara, Indonesia. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 4, 2011. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8041092
- FEI number
- 3002914051
- Address
- Jl.pulau Irian (kawasan Industry Medan) JL. Kom Laut Yos Sudarso KM 10.5, MEDAN Sumatera Utara, Indonesia, 20242
- Owner or operator
- PT. INTAN HEVEA INDUSTRY (8041092)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 20, 2007
- Registered through
- 2027
- Brand names listed
- MULTIPLE, SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES,NON-STERILE, UNISEAL Powder Free Latex Examination Gloves Blue Colored
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer, Specification developer | 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 4, 2011 | K111923 | SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Pt. Intan Hevea Industry | accessdata.fda.gov |
| February 4, 1999 | K983614 | UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED) | LYY | Substantially Equivalent | American Healthcare Products (M) Sdn Bhd | accessdata.fda.gov |
| September 15, 1989 | K894480 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | Pt. Intan Hevea Industry | accessdata.fda.gov |
Compare with other makers
Updated November 4, 2011. 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.