FDA applicant
Baldur Systems Corp.
FDA records 6 decisions for Baldur Systems Corp. (Hayward, CA) from 1989 to 1998: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LYZ (Vinyl 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 Baldur Systems Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Baldur Systems Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Baldur Systems Corp.’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