Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sunmax Enterprise Shanghai Co. , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
141 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090336 | SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATI | Sunmax Enterprise Shanghai Co. , Ltd. | 2009-07-01 | 141 | 0 |
| K011765 | SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-16 | 70 | 0 |
| K011717 | SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-14 | 71 | 0 |
| K964964 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Sunmax Enterprise Shanghai Co. , Ltd. | 1997-02-07 | 58 | 0 |
| K960746 | SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOV | Sunmax Enterprise Shanghai Co. , Ltd. | 1996-06-27 | 125 | 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