Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Anhui 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) |
|---|---|---|---|---|---|
| K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue | Anhui Intco Medical Products Co., Ltd. | 2024-03-01 | 295 | 0 |
| K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-St | Anhui Intco Medical Products Co., Ltd. | 2024-01-26 | 78 | 0 |
| K191092 | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | Anhui Intco Medical Products Co., Ltd. | 2019-07-22 | 89 | 0 |
| K190095 | Powder-Free Clear Vinyl Patient Examination Gloves | Anhui Intco Medical Products Co., Ltd. | 2019-06-20 | 149 | 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