Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dr. Boo 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) |
|---|---|---|---|---|---|
| K941240 | DR. BOO POWDER-FREE LATEX EXAM GLOVES | Dr. Boo Co., Ltd. | 1994-06-21 | 98 | 0 |
| K891313 | PATIENT EXAMINATION GLOVES | Dr. Boo Co., Ltd. | 1989-05-04 | 55 | 0 |
| K891271 | PATIENT EXAMINATION GLOVE (LATEX) | Dr. Boo Co., Ltd. | 1989-03-22 | 13 | 0 |
| K891242 | PATIENT EXAMINATION GLOVES (LATEX) | Dr. Boo Co., Ltd. | 1989-03-21 | 14 | 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