Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shun Thai Rubber Gloves Industry Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
224 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051333 | NITRILE EXAMINATION GLOVES, POWDER FREE | Shun Thai Rubber Gloves Industry Co., Ltd. | 2005-07-22 | 60 | 0 |
| K982416 | SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, S | Shun Thai Rubber Gloves Industry Co., Ltd. | 1998-11-24 | 134 | 0 |
| K952695 | BOSTON MEDICAL LATEX EXAM GLOVES | Shun Thai Rubber Gloves Industry Co., Ltd. | 1995-08-11 | 58 | 0 |
| K930139 | HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES | Shun Thai Rubber Gloves Industry Co., Ltd. | 1993-08-24 | 224 | 0 |
| K892554 | STERILE PATIENT EXAMINATION GLOVE | Shun Thai Rubber Gloves Industry Co., Ltd. | 1989-05-25 | 45 | 0 |
| K891300 | NON-STERILE PATIENT EXAMINATION GLOVE | Shun Thai Rubber Gloves Industry Co., Ltd. | 1989-04-05 | 23 | 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