Thai Nippon Rubber Industry Public Company Limited.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Thai Nippon Rubber Industry Public Company Limited.” (first 2018, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 262 days. Since 2017 the median was 262 days, against 140 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 262 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 3 | 233 |
| 2022 | 1 | 263 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Thai Nippon Rubber Industry Public Company Limited. took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 3 | 3 |
| NUC | Lubricant, Personal | 2 | 2 |
Review panels
Most recent Thai Nippon Rubber Industry Public Company Limited. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220273 | Onetouch Non-paraben Lubricant Gel | NUC | 2022-10-21 | 263 |
| K210095 | Playboy Premium Silicone Lubricant | NUC | 2021-11-23 | 313 |
| K211450 | Playboy 3 Contour Condom | HIS | 2021-09-30 | 143 |
| K210294 | One Touch Spiral Condom | HIS | 2021-09-23 | 233 |
| K171213 | One Touch Condom with Benzocaine | HIS | 2018-01-12 | 262 |
Recalls
openFDA lists no recalls under a recalling firm named Thai Nippon Rubber Industry Public Company Limited..
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.
Device clinical trials
An industry sponsor named Thai Nippon Rubber Industry Public Company Limited. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06595836: Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Recruiting, started 2024-01-02)
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 Co., Ltd. (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 Public Company Limited.?
FDA lists 5 510(k) clearances under the applicant name “Thai Nippon Rubber Industry Public Company Limited.” (first 2018, latest 2022), across 2 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 Public Company Limited.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thai Nippon Rubber Industry Public Company Limited. is 262 days. Since 2017: 262 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Thai Nippon Rubber Industry Public Company Limited.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 3); NUC (Lubricant, Personal, 2).
Next steps
- See all 5 Thai Nippon Rubber Industry Public Company Limited. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Thai Nippon Rubber Industry Public Company Limited.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.