FDA applicant
Smart Glove Corp. Sdn Bhd
FDA records 32 decisions for Smart Glove Corp. Sdn Bhd (Klang Selangor, MY) from 1998 to 2022: 32 510(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 195 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. No recall is linked to its devices.
FDA’s records also spell it “Smart Glove Corporation Sdn. Bhd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smart Glove Corp. Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Smart Glove Corp. Sdn Bhd’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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