Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shandong Intco Medical 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) |
|---|---|---|---|---|---|
| K233042 | Sterile Nitrile Examination Gloves Powder Free Tested for Us | Shandong Intco Medical Products Co, Ltd. | 2023-12-06 | 72 | 0 |
| K231408 | Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colore | Shandong Intco Medical Products Co, Ltd. | 2023-08-11 | 88 | 0 |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra | Shandong Intco Medical Products Co, Ltd. | 2023-02-22 | 118 | 0 |
| K213509 | Latex Examination Gloves, Powder Free | Shandong Intco Medical Products Co, Ltd. | 2022-04-08 | 157 | 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