Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Lon Tai Chemical Industrial Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895018 | SURGICAL GLOVES | Lon Tai Chemical Industrial Co., Ltd. | 1990-02-16 | 192 | 0 |
| K893449 | LATEX EXAMINATION GLOVES | Lon Tai Chemical Industrial Co., Ltd. | 1989-09-18 | 138 | 0 |
| K891504 | PATIENT EXAMINATION GLOVE (LATEX) | Lon Tai Chemical Industrial Co., Ltd. | 1989-08-30 | 167 | 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