Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Modern Rubber Industrial Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900669 | HYPO-ALLERGENIC SURGICAL GLOVES | Modern Rubber Industrial Co., Ltd. | 1990-04-16 | 66 | 0 |
| K893492 | LATEX EXAMINATION GLOVES | Modern Rubber Industrial Co., Ltd. | 1989-08-24 | 112 | 0 |
| K892056 | SURGICAL LATEX STERILE GLOVES | Modern Rubber Industrial Co., Ltd. | 1989-06-08 | 76 | 0 |
| K892064 | LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN | Modern Rubber Industrial Co., Ltd. | 1989-04-26 | 27 | 0 |
| K891065 | LATEX EXAMINATION GLOVES | Modern Rubber Industrial Co., Ltd. | 1989-03-16 | 15 | 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