Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai Glovmax Enterprise 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) |
|---|---|---|---|---|---|
| K021000 | SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATIO | Shanghai Glovmax Enterprise Co.,Ltd | 2002-05-31 | 64 | 0 |
| K021001 | SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINAT | Shanghai Glovmax Enterprise Co.,Ltd | 2002-05-16 | 49 | 0 |
| K993859 | SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PAT | Shanghai Glovmax Enterprise Co.,Ltd | 2000-01-12 | 58 | 0 |
| K993880 | SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATI | Shanghai Glovmax Enterprise Co.,Ltd | 2000-01-12 | 58 | 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