FDA applicant
Semperit Investments Asia Pte, Ltd.
FDA records 4 decisions for Semperit Investments Asia Pte, Ltd. (Singapore, SG) from 2017 to 2023: 4 510(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 212 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. 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 Semperit Investments Asia Pte, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Semperit Investments Asia Pte, Ltd.’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 “Semperit”
FDA records each applicant name separately; these may or may not be the same firm.