FDA applicant
Top Glove Sdn. Bhd.
FDA records 18 decisions for Top Glove Sdn. Bhd. (Klang, Selangor, MY) from 1991 to 2026: 18 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 205 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. 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 Top Glove Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Top Glove 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