Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shun Thai Rubber Gloves Industry Public Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
267 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092617 | ROYAL GUARD | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2010-05-20 | 267 | 0 |
| K060229 | POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABE | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2006-03-15 | 44 | 0 |
| K052030 | SURGEON'S GLOVE, POWDER FREE | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2005-09-13 | 48 | 0 |
| K052031 | POWDERED LATEX SURGEON'S GLOVE | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2005-09-12 | 47 | 0 |
| K040406 | POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION G | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2004-05-14 | 87 | 0 |
| K040408 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PR | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2004-03-17 | 29 | 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