FDA applicant
Encompass Industries Sdn. Bhd.
FDA records 3 decisions for Encompass Industries Sdn. Bhd. (Kemaman, MY) from 2019 to 2025: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). Since 2016 its 510(k)s took a median of 152 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 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 Encompass Industries 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 2019.
Planning a device like Encompass Industries 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 “Encompass”
FDA records each applicant name separately; these may or may not be the same firm.