Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shandong Blue Sail Innovation Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103619 | SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ | Shandong Blue Sail Innovation Co., Ltd. | 2011-08-10 | 243 | 0 |
| K102161 | BLUE SAIL INNOVATION | Shandong Blue Sail Innovation Co., Ltd. | 2010-10-08 | 67 | 0 |
| K102160 | STRETCH VINYL EXAMINATION GLOVE POWDER FREE | Shandong Blue Sail Innovation Co., Ltd. | 2010-10-04 | 63 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda