FDA applicant
Ansell Healthcare Products, LLC
FDA records 36 decisions for Ansell Healthcare Products, LLC (Dothan, AL) from 2000 to 2023: 36 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 202 days from receipt to decision, against 185 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 10 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Ansell Healthcare Products, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ansell Healthcare Products, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like Ansell Healthcare Products, LLC’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 “Ansell”
FDA records each applicant name separately; these may or may not be the same firm.