FDA applicant
Riverstone Resources Sdn Bhd
FDA records 15 decisions for Riverstone Resources Sdn Bhd (Bukit Beruntung, MY) from 1999 to 2022: 15 510(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 88 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 5 of them its own earlier devices. 24 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Riverstone Resources Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
24in 2016
Class I Class II/III not classified
Planning a device like Riverstone Resources 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