FDA applicant
Wear Safe Malaysia Sdn. Bhd.
FDA records 14 decisions for Wear Safe Malaysia Sdn. Bhd. (Port Klang, Selangor, D.E., MY) from 1998 to 2017: 14 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). No recall is linked to its devices.
FDA’s records also spell it “Wear Safe (Malaysia) Sdn. Bhd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wear Safe Malaysia Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Wear Safe Malaysia 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) ReportOther applicant names beginning “Wear”
FDA records each applicant name separately; these may or may not be the same firm.