Polymint Industrial Co. , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Polymint Industrial Co. , Ltd.” (first 1989, latest 1994), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 117 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 | 0 | — |
| 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 |
|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| LRR | First Aid Kit With Drug | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
Review panels
Most recent Polymint Industrial Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932457 | SPYROGEL WOUND DRESSING | KGX | 1994-02-09 | 264 |
| K931634 | VARIOUS KITS | LRR | 1993-11-30 | 243 |
| K921775 | SPYROFLEX WOUND CLOSURES | FPX | 1992-05-19 | 39 |
| K911649 | MITRASHEER TRANSPLANT DRESSING | MGP | 1991-08-07 | 117 |
| K891644 | SAMBORD LATEX PATIENT EXAMINATION GLOVES | LYY | 1989-06-19 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Polymint Industrial 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Polymint Industrial Co. , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Polymint Industrial Co. , Ltd.” (first 1989, latest 1994), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Polymint Industrial Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polymint Industrial Co. , Ltd. is 117 days.
Which FDA product codes appear under Polymint Industrial Co. , Ltd.?
The most frequent FDA product codes under this applicant name are FPX (Strip, Adhesive, Closure, Skin, 1); KGX (Tape And Bandage, Adhesive, 1); LRR (First Aid Kit With Drug, 1).
Next steps
- See all 5 Polymint Industrial Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FPX, Polymint Industrial 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.