FDA applicant
Oak Carolina, Inc.
FDA records 3 decisions for Oak Carolina, Inc. (Travelers Rest, SC) from 1996 to 1998: 3 510(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 Oak Carolina, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Oak Carolina, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Oak Carolina, 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) Report