Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hycare Intl. 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) |
|---|---|---|---|---|---|
| K022530 | POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR | Hycare Intl. Co., Ltd. | 2002-08-26 | 26 | 0 |
| K020042 | HYCARE LATEX EXAMINATION GLOVE, POWDER FREE | Hycare Intl. Co., Ltd. | 2002-07-30 | 204 | 0 |
| K010875 | HYCARE LATEX EXAMINATION GLOVE, POWDERED | Hycare Intl. Co., Ltd. | 2001-06-07 | 76 | 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