FDA applicant
Shandong Blue Sail Innovation Co., Ltd.
FDA records 3 decisions for Shandong Blue Sail Innovation Co., Ltd. (Weifang, Shandong, CN) from 2010 to 2011: 3 510(k) clearances. All are in product code 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 Shandong Blue Sail Innovation Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2010high 2 (2010) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Shandong Blue Sail Innovation Co., 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) Report