Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thai Nippon Rubber Industry Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
529 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142790 | OneTouch Lubricant Gel | Thai Nippon Rubber Industry Co., Ltd. | 2015-07-30 | 307 | 0 |
| K081265 | THAI NIPPON MALE LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2009-10-16 | 529 | 0 |
| K032909 | THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2003-12-16 | 90 | 0 |
| K011253 | FLAVORED MALE LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2001-07-20 | 87 | 0 |
| K001978 | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | Thai Nippon Rubber Industry Co., Ltd. | 2000-08-08 | 40 | 0 |
| K994095 | LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2000-01-18 | 46 | 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