FDA applicant
Pt.Shamrock Manufacturing Corp.
FDA records 7 decisions for Pt.Shamrock Manufacturing Corp. (Chino, CA) from 2001 to 2008: 7 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer 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 Pt.Shamrock Manufacturing Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pt.Shamrock Manufacturing 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