Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
126 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2022-05-26 | 86 | 0 |
| K042645 | POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2004-11-26 | 60 | 0 |
| K031157 | POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WA | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2003-08-15 | 126 | 0 |
| K022566 | POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WAT | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2002-10-15 | 74 | 0 |
| K012709 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROT | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2001-10-01 | 48 | 0 |
| K002087 | BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (5 | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2000-09-13 | 65 | 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