Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Thai Nippon Rubber Industry Public Company Limited. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
262 daysmedian FDA review time
313 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220273 | Onetouch Non-paraben Lubricant Gel | Thai Nippon Rubber Industry Public Company Limited. | 2022-10-21 | 263 | 0 |
| K210095 | Playboy Premium Silicone Lubricant | Thai Nippon Rubber Industry Public Company Limited. | 2021-11-23 | 313 | 0 |
| K211450 | Playboy 3 Contour Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-30 | 143 | 0 |
| K210294 | One Touch Spiral Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-23 | 233 | 0 |
| K171213 | One Touch Condom with Benzocaine | Thai Nippon Rubber Industry Public Company Limited. | 2018-01-12 | 262 | 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