Thai Nippon Rubber Industry Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Thai Nippon Rubber Industry Co., Ltd.” (first 2000, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 307 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 4 | 4 |
| LTZ | Condom With Nonoxynol-9 | 1 | 1 |
| NUC | Lubricant, Personal | 1 | 1 |
Review panels
Most recent Thai Nippon Rubber Industry Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142790 | OneTouch Lubricant Gel | NUC | 2015-07-30 | 307 |
| K081265 | THAI NIPPON MALE LATEX CONDOM | HIS | 2009-10-16 | 529 |
| K032909 | THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM | HIS | 2003-12-16 | 90 |
| K011253 | FLAVORED MALE LATEX CONDOM | HIS | 2001-07-20 | 87 |
| K001978 | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | LTZ | 2000-08-08 | 40 |
| K994095 | LATEX CONDOM | HIS | 2000-01-18 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named Thai Nippon Rubber Industry Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Thai Nippon Rubber Industry Public Company Limited. (6 510(k)s)
- Thai Hua Holding Co., Ltd. (3 510(k)s)
- Thai Rubber Gloves Co., Ltd. (2 510(k)s)
- Thai Rubber Industry Company Limited (2 510(k)s)
- Thai Chong Chemical Industrial Co., Ltd. (1 510(k)s)
- Thai Disposable Products Co., Ltd. (1 510(k)s)
- Thai Fuji Latex Co., Ltd. (1 510(k)s)
- Thai Hospital Products Co., Ltd. (1 510(k)s)
- Thai Latex, Inc. (1 510(k)s)
- Thai Medical Glove Co., Ltd. (1 510(k)s)
- Thai Medical Industries Co., Ltd. (1 510(k)s)
- Thai Medical Latex Glove Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Thai Nippon Rubber Industry Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Thai Nippon Rubber Industry Co., Ltd.” (first 2000, latest 2015), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thai Nippon Rubber Industry Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thai Nippon Rubber Industry Co., Ltd. is 88 days.
Which FDA product codes appear under Thai Nippon Rubber Industry Co., Ltd.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 4); LTZ (Condom With Nonoxynol-9, 1); NUC (Lubricant, Personal, 1).
Next steps
- See all 6 Thai Nippon Rubber Industry Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Thai Nippon Rubber Industry Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.