FDA applicant
Flexitech Sdn. Bhd.
FDA records 6 decisions for Flexitech Sdn. Bhd. (Klang, Selangor, MY) from 1999 to 2000: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer 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 Flexitech Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Flexitech Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Flexitech 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