Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai Poseidon Plastic Products Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
159 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001836 | NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-07-26 | 40 | 0 |
| K001837 | NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-07-11 | 25 | 0 |
| K001549 | MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (W | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-06-12 | 25 | 0 |
| K001128 | NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-05-23 | 46 | 0 |
| K992979 | SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GL | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-02-09 | 159 | 0 |
| K982885 | PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE | Shanghai Poseidon Plastic Products Co., Ltd. | 1998-12-04 | 109 | 0 |
| K964545 | POWDER FREE VINYL EXAMINATION GLOVE | Shanghai Poseidon Plastic Products Co., Ltd. | 1996-12-30 | 47 | 0 |
| K954381 | SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES | Shanghai Poseidon Plastic Products Co., Ltd. | 1995-12-11 | 83 | 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