Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Jiangsu Sunshine Plastic Products, Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100975 | NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLO | Jiangsu Sunshine Plastic Products, Co., Ltd. | 2010-08-17 | 130 | 0 |
| K100977 | PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE | Jiangsu Sunshine Plastic Products, Co., Ltd. | 2010-08-12 | 126 | 0 |
| K100978 | POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE | Jiangsu Sunshine Plastic Products, Co., Ltd. | 2010-08-12 | 126 | 0 |
| K100979 | NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE E | Jiangsu Sunshine Plastic Products, Co., Ltd. | 2010-07-02 | 85 | 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