FDA applicant
Yty Industry (Manjung) Sdn Bhd
FDA records 28 decisions for Yty Industry (Manjung) Sdn Bhd (Sparks, NV) from 1989 to 2026: 28 510(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 134 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 6 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 Yty Industry (Manjung) Sdn Bhd’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 2007.
Planning a device like Yty Industry (Manjung) 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