Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Heyuan Hongli Industries, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
35 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030997 | POWDERED VINYL EXAM GLOVES, WHITE | Heyuan Hongli Industries, Inc. | 2003-05-02 | 35 | 0 |
| K022305 | MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: | Heyuan Hongli Industries, Inc. | 2002-08-08 | 23 | 0 |
| K011413 | POWDER-FREE VINYL EXAM GLOVE, YELLOW | Heyuan Hongli Industries, Inc. | 2001-06-05 | 28 | 0 |
| K011414 | POWDERED VINAL EXAM GLOVES | Heyuan Hongli Industries, Inc. | 2001-06-05 | 28 | 0 |
| K011412 | POWDER-FREE VINYL EXAM GLOVES | Heyuan Hongli Industries, Inc. | 2001-05-31 | 23 | 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