Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Beijing Reagent Latex Products 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) |
|---|---|---|---|---|---|
| K211515 | Nitrile Examination Gloves | Beijing Reagent Latex Products Co., Ltd. | 2021-08-24 | 99 | 0 |
| K062797 | POWDERED LATEX SURGICAL GLOVE | Beijing Reagent Latex Products Co., Ltd. | 2007-04-11 | 204 | 0 |
| K012104 | SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES | Beijing Reagent Latex Products Co., Ltd. | 2001-08-21 | 47 | 0 |
| K010947 | SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTE | Beijing Reagent Latex Products Co., Ltd. | 2001-05-25 | 57 | 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