FDA applicant
Hartalega Sdn Bhd
FDA records 61 decisions for Hartalega Sdn Bhd (Kuala Lumpur, MY) from 1989 to 2020: 61 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. 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 Hartalega Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
3in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hartalega 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) ReportOther applicant names beginning “Hartalega”
FDA records each applicant name separately; these may or may not be the same firm.