FDA applicant
Influx Pacific Sdn. Bhd.
FDA records 5 decisions for Influx Pacific Sdn. Bhd. (Malacca, West Malaysia, MY) from 1989 to 1998: 5 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) 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 Influx Pacific Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Influx Pacific Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Influx Pacific Sdn. Bhd.’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