FDA applicant
Kenwell International, Ltd.
FDA records 5 decisions for Kenwell International, Ltd. (Great Neck,, NY) from 1990 to 1998: 5 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LYY (Latex 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 Kenwell International, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kenwell International, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kenwell International, Ltd.’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