FDA applicant
Careglove Global Sdn. Bhd.
FDA records 8 decisions for Careglove Global Sdn. Bhd. (Seremban, MY) from 2017 to 2025: 8 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 196 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 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 Careglove Global Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Careglove Global 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