FDA applicant
Hartalega NGC Sdn. Bhd.
FDA records 31 decisions for Hartalega NGC Sdn. Bhd. (Sepang, MY) from 2014 to 2026: 31 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 7 of them its own earlier devices. 1 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 NGC Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Hartalega NGC 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.