Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Motex Healthcare Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
257 daysmedian FDA review time
608 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123126 | MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412( | Shanghai Motex Healthcare Co., Ltd. | 2014-06-04 | 608 | 0 |
| K132802 | MOTEX POWDERED NITRILE SURGICAL GLOVES | Shanghai Motex Healthcare Co., Ltd. | 2014-05-21 | 257 | 0 |
| K122557 | MOTEX POWDER-FREE NITRILE SURGICAL GLOVES | Shanghai Motex Healthcare Co., Ltd. | 2013-10-03 | 407 | 0 |
| K063757 | MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGI | Shanghai Motex Healthcare Co., Ltd. | 2007-07-27 | 220 | 0 |
| K041276 | POWDER-FREE NITRILE EXAMINATION GLOVES | Shanghai Motex Healthcare Co., Ltd. | 2004-08-20 | 100 | 0 |
| K030207 | NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #77 | Shanghai Motex Healthcare Co., Ltd. | 2003-05-02 | 101 | 0 |
| K020837 | MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE | Shanghai Motex Healthcare Co., Ltd. | 2002-12-02 | 263 | 0 |
| K013261 | MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE | Shanghai Motex Healthcare Co., Ltd. | 2001-11-29 | 59 | 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