FDA applicant
Ever Global (Vietnam) Enterprise Corporation
FDA records 8 decisions for Ever Global (Vietnam) Enterprise Corporation (Dong Nai Province, VN) from 2017 to 2025: 8 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). Since 2016 its 510(k)s took a median of 167 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ever Global (Vietnam) Enterprise Corp”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ever Global (Vietnam) Enterprise Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Ever Global (Vietnam) Enterprise…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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