FDA applicant
Elite International, Inc.
FDA records 4 decisions for Elite International, Inc. (Rowland Heights, CA) from 2003 to 2004: 4 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Elite International, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Elite International, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Elite International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Elite”
FDA records each applicant name separately; these may or may not be the same firm.