FDA applicant
Omnigrace, Ltd.
FDA records 8 decisions for Omnigrace, Ltd. (Hatyai, Songkhla, TH) from 1997 to 2000: 8 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and 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 Omnigrace, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Omnigrace, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Omnigrace, Ltd.’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 “Omnigrace”
FDA records each applicant name separately; these may or may not be the same firm.