FDA applicant
Healthcare Gloves Sdn Bhd
FDA records 2 decisions for Healthcare Gloves Sdn Bhd (Batu Caves Selangor, MY) from 1989 to 1994: 2 510(k) clearances. All are in product code LYY (Latex Patient Examination Glove). 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 Healthcare Gloves Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Healthcare Gloves Sdn Bhd since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Healthcare Gloves 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