Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
W.A. Rubbermate 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) |
|---|---|---|---|---|---|
| K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Ste | W.A. Rubbermate Co., Ltd. | 2024-02-13 | 83 | 0 |
| K110418 | POWDER FREE NITRILE EXAMINATION GLOVES | W.A. Rubbermate Co., Ltd. | 2011-07-13 | 149 | 0 |
| K021041 | WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES | W.A. Rubbermate Co., Ltd. | 2002-07-30 | 120 | 0 |
| K971200 | W.A. | W.A. Rubbermate Co., Ltd. | 1997-08-29 | 150 | 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