Data / Medical devices / United States / Hilo Industries LLC
Hilo Industries LLC: FDA-registered device maker in Mesa, AZ, United States, 1 510(k) clearance
Hilo Industries LLC is registered with the FDA (registration 3034226814) in Mesa, AZ, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034226814
- Address
- 7035 E Pecos Rd, Ste 1001 Bldg 1, Mesa, AZ, United States, 85212
- Owner or operator
- Hilo Industries LLC (10073187)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 11, 2021
- Registered through
- 2026
- Brand names listed
- Isolation Gown, Standard Surgical Gown, Surgical Drapes, Surgical Gown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 4, 2011 | K093835 | BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN | FYA | Substantially Equivalent | Bam Corp., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 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.